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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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SLD+ 180A - B271ART1800

No Description
Meditech International Inc
SLD+ 180A
In Commercial Distribution

  • B271ART1800 ()


  • Red-light phototherapy unit, professional

K-Laser - B317SPCLTHP0

Device indicated for emitting energy in the Infrared Spectrum to provide topical heating for the purpose of elevating tissue temperature for temporary relief of minor muscle and joint pain, muscle spasm, pain and stiffness associated with arthritis and promoting relaxation of the muscle tissue and to temporarily increase local blood circulation
ELTECH KLASER SRL
Speciale Live Therapy Plus
In Commercial Distribution

  • B317SPCLTHP0 ()


  • Musculoskeletal/physical therapy laser, professional

K-Laser - B317SPCLTHM0

Device indicated for emitting energy in the Infrared Spectrum to provide topical heating for the purpose of elevating tissue temperature for temporary relief of minor muscle and joint pain, muscle spasm, pain and stiffness associated with arthritis and promoting relaxation of the muscle tissue and to temporarily increase local blood circulation
ELTECH KLASER SRL
Speciale Live Therapy
In Commercial Distribution

  • B317SPCLTHM0 ()


  • Musculoskeletal/physical therapy laser, professional

K-Laser - B317KPLUS300

Device indicated for emitting energy in the Infrared Spectrum to provide topical heating for the purpose of elevating tissue temperature for temporary relief of minor muscle and joint pain, muscle spasm, pain and stiffness associated with arthritis and promoting relaxation of the muscle tissue and to temporarily increase local blood circulation
ELTECH KLASER SRL
K-Laser Cube Plus 30
In Commercial Distribution

  • B317KPLUS300 ()


  • Musculoskeletal/physical therapy laser, professional

K-Laser - B317KPERF300

Device indicated for emitting energy in the Infrared Spectrum to provide topical heating for the purpose of elevating tissue temperature for temporary relief of minor muscle and joint pain, muscle spasm, pain and stiffness associated with arthritis and promoting relaxation of the muscle tissue and to temporarily increase local blood circulation. Device only for veterinary use.
ELTECH KLASER SRL
K-Laser Cube Performance 30
In Commercial Distribution

  • B317KPERF300 ()


  • Musculoskeletal/physical therapy laser, professional

K-Laser - B317KCUBE4P0

Device indicated for emitting energy in the Infrared Spectrum to provide topical heating for the purpose of elevating tissue temperature for temporary relief of minor muscle and joint pain, muscle spasm, pain and stiffness associated with arthritis and promoting relaxation of the muscle tissue and to temporarily increase local blood circulation. Device only for veterinary use.
ELTECH KLASER SRL
K-Laser Cube4 Performance
In Commercial Distribution

  • B317KCUBE4P0 ()


  • Musculoskeletal/physical therapy laser, professional

K-Laser - B317KCUBE40

Device indicated for emitting energy in the Infrared Spectrum to provide topical heating for the purpose of elevating tissue temperature for temporary relief of minor muscle and joint pain, muscle spasm, pain and stiffness associated with arthritis and promoting relaxation of the muscle tissue and to temporarily increase local blood circulation
ELTECH KLASER SRL
K-Laser Cube4
In Commercial Distribution

  • B317KCUBE40 ()


  • Musculoskeletal/physical therapy laser, professional

K-Laser - B317KCUBE30

Device indicated for emitting energy in the Infrared Spectrum to provide topical heating for the purpose of elevating tissue temperature for temporary relief of minor muscle and joint pain, muscle spasm, pain and stiffness associated with arthritis and promoting relaxation of the muscle tissue and to temporarily increase local blood circulation
ELTECH KLASER SRL
K-Laser Cube3
In Commercial Distribution

  • B317KCUBE30 ()


  • Musculoskeletal/physical therapy laser, professional

K-Laser - B317KCUBE20

Device indicated for emitting energy in the Infrared Spectrum to provide topical heating for the purpose of elevating tissue temperature for temporary relief of minor muscle and joint pain, muscle spasm, pain and stiffness associated with arthritis and promoting relaxation of the muscle tissue and to temporarily increase local blood circulation
ELTECH KLASER SRL
K-Laser Cube2
In Commercial Distribution

  • B317KCUBE20 ()


  • Musculoskeletal/physical therapy laser, professional

K-Laser - B317KCUBE0

Device indicated for emitting energy in the Infrared Spectrum to provide topical heating for the purpose of elevating tissue temperature for temporary relief of minor muscle and joint pain, muscle spasm, pain and stiffness associated with arthritis and promoting relaxation of the muscle tissue and to temporarily increase local blood circulation
ELTECH KLASER SRL
K-Laser Cube
In Commercial Distribution

  • B317KCUBE0 ()


  • Musculoskeletal/physical therapy laser, professional

Caring Mill - 00810025927806

Light therapy wrap
LIGHT TREE TECHNOLOGY INDIA PRIVATE LIMITED
CM-ZLD-80-MP
In Commercial Distribution

  • 00810025927806 ()


  • Musculoskeletal infrared phototherapy unit, wearable

Laser Applicator 5401 - 00816864020548

785 nm laser applicator
METTLER ELECTRONICS CORP.
5401
In Commercial Distribution

  • 00816864020548 ()
5401

  • Musculoskeletal/physical therapy laser, professional

Laser Sys*Stim 540 - 00816864020425

Therapeutic laser and light therapy
METTLER ELECTRONICS CORP.
ME 540
In Commercial Distribution

  • 00816864020425 ()

  • Weight: 5.5 Pound
ME 540

  • Musculoskeletal/physical therapy laser, professional

Weberneedle - B45510551

No Description
Weber Medical GmbH
weberneedle® basic "compact edition" laser
In Commercial Distribution

  • B45510551 ()


  • Musculoskeletal infrared phototherapy unit, non-wearable

Migun - B556HY7770

Provides infrared heat to different areas of the body. It is indicated for the temporary relief of minor muscle and joint pain. the temporary relief of joint pain associated with arthritis. muscle spasms, minor sprains and strains, minor muscular back pain, muscle relaxation therapy and temporary increase of circulation where applied.
MIGUN LIFE CO., LTD
HY777
In Commercial Distribution

  • B556HY7770 ()


  • Musculoskeletal infrared phototherapy unit, non-wearable

Vevazz LCD - B552VEVAZZLCD0

The Vevazz is a device that emits energy in the infrared spectrum and is to be used to provide topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint pain, arthritis, stiffness or muscle spasms; the temporary increasing of local blood circulation and/or the temporary relaxation of muscle.
VEVAZZ LLC
Vevazz LCD
In Commercial Distribution

  • B552VEVAZZLCD0 ()


  • Musculoskeletal/physical therapy laser, home-use

Xianhe Double-Headed TDP Infrared Therapy Lamp - B465CQ360

The CQ-36 / D-04B TDP therapy lamp has two independent emission heads, each containing a mineral plate consisting of 33 elements essential to the human body. When this mineral plate is activated by a built-in heating element begins to emit FIR (far infrared) waves along with the ionized minerals which easily penetrates deep into the body to be absorbed. The CQ-36 lamp is a free standing floor lamp with a 24" diameter wheeled base for convenient transport. With the articulating arms, each emission head can be positioned as low as 12" to as high as 52" from the floor. Tilt and swivel head allow multiple angles of treatment. Quick and easy assembly.
A & A MEDICAL SUPPLIES INC.
CQ-36
In Commercial Distribution

  • B465CQ360 ()

  • Weight: 25 Pound
  • Width: 24 Inch
  • Adjustable Min/Max Height: 33.5"/62" above floor
D-04B

  • Musculoskeletal infrared phototherapy unit, non-wearable

Xianhe TDP Infrared Therapy Lamp - B465CQ29II0

The CQ-29II / D-17 TDP infrared therapy lamp contains a mineral plate consisting of 33 elements essential to the human body. When this mineral plate is activated by a built-in infrared heat tubes in the TDP lamp head, it begins to emit FIR (far infrared) waves which, along with the ionized minerals, easily penetrates deep into the body to be absorbed. The CQ-29II lamp is a free standing floor lamp with a 24" diameter wheeled base for convenient transport. With the telescoping main post and articulating neck, the emission head can be positioned as low as 21" to as high as 61" from the floor with the post fully extended. Tilt and swivel head allow multiple angles of treatment. Quick and easy assembly.
A & A MEDICAL SUPPLIES INC.
CQ-29II
In Commercial Distribution

  • B465CQ29II0 ()

  • Weight: 25 Pound
  • Width: 24 Inch
  • Adjustable Min/Max Height: 33.5"/62" above floor
D-17

  • Musculoskeletal infrared phototherapy unit, non-wearable

Xianhe TDP Infrared Therapy Lamp - B465CQ29CN0

The CQ-29CN / D-11 TDP infrared therapy lamp contains a mineral plate consisting of 33 elements essential to the human body. When this mineral plate is activated by a built-in heating coil in the TDP lamp head, it begins to emit FIR (far infrared) waves which, along with the ionized minerals, easily penetrates deep into the body to be absorbed. A digital control panel with a back-lit LCD screen is located on the stand. Get precise controls over different aspects of treatment. Set treatment duration with the built-in timer by pressing the Timing button—adjustable from 30-60 minutes in 5 minute increments. Power level is also adjustable by pressing Adjustment button to set power from 50-100% in 10% increments. The LCD display is large and clear giving you all the information you need at a glance. The CQ-29CN lamp is a free standing floor lamp with a 24" diameter wheeled base for convenient transport. With the telescoping main post and articulating neck, the emission head can be positioned as low as 21" to as high as 61" from the floor with the post fully extended. Tilt and swivel head allow multiple angles of treatment. Quick and easy assembly.
A & A MEDICAL SUPPLIES INC.
CQ-29CN
In Commercial Distribution

  • B465CQ29CN0 ()

  • Weight: 25 Pound
  • Width: 24 Inch
  • Adjustable Min/Max Height: 33.5"/62" above floor
D-11

  • Musculoskeletal infrared phototherapy unit, non-wearable

Xianhe TDP Infrared Therapy Lamp - B465CQ290

The CQ-29 / D-04A TDP infrared therapy lamp contains a mineral plate consisting of 33 elements essential to the human body. When this mineral plate is activated by a built-in heating coil in the TDP lamp head, it begins to emit FIR (far infrared) waves which, along with the ionized minerals, easily penetrates deep into the body to be absorbed. The CQ-29 lamp is a free standing floor lamp with a 24" diameter wheeled base for convenient transport. With the telescoping main post and articulating neck, the emission head can be positioned as low as 21" to as high as 61" from the floor with the post fully extended. Tilt and swivel head allow multiple angles of treatment. Quick and easy assembly.
A & A MEDICAL SUPPLIES INC.
CQ-29
In Commercial Distribution

  • B465CQ290 ()

  • Adjustable Min/Max Height: 33.5"/62" above floor
  • Width: 24 Inch
  • Weight: 25 Pound
D-04A

  • Musculoskeletal infrared phototherapy unit, non-wearable

Xianhe TDP Infrared Therapy Lamp - B465CQ270

The CQ-27 / D-04 TDP lamp provides penetrating heat therapy to elevate tissue temperature, temporarily increase local blood circulation, and temporarily relieve minor muscle and joint pain and stiffness. The head contains a mineral plate consisting of 33 elements essential to the human body. As this mineral plate is activated by a built-in heating element in the TDP lamp, it begins to emit FIR (far infrared) waves which, along with the ionized minerals, easily penetrates deep into the body to be absorbed. The CQ-27 lamp is a free standing floor lamp with a 24" diameter wheeled base for convenient transport. With the telescoping main post and articulating neck, the emission head can be positioned as low as 21" to as high as 61" from the floor with the post fully extended. Tilt and swivel head allow multiple angles of treatment. Quick and easy assembly.
A & A MEDICAL SUPPLIES INC.
CQ-27
In Commercial Distribution

  • B465CQ270 ()

  • Weight: 25 Pound
  • Width: 24 Inch
  • Adjustable Min/Max Height: 33.5"/62" above floor
D-04

  • Musculoskeletal infrared phototherapy unit, non-wearable

Xianhe Desktop TDP Infrared Therapy Lamp - B465CQ180

The CQ-18 / D-05 TDP therapy lamp head contains a mineral plate consisting of 33 elements essential to the human body. When this mineral plate is activated by a built-in heating element begins to emit FIR (far infrared) waves along with the ionized minerals which easily penetrates deep into the body to be absorbed. The CQ-36 lamp is a desk lamp with the control panel built into the base. The articulating arm allows you to easily position the emission head at different heights, while tilt and swivel head allows for multiple angles of treatment.
A & A MEDICAL SUPPLIES INC.
CQ-18
In Commercial Distribution

  • B465CQ180 ()

  • Adjustable Min/Max Height: 33.5"/62" above floor
  • Width: 24 Inch
  • Weight: 25 Pound
D-05

  • Musculoskeletal infrared phototherapy unit, non-wearable

Scanning System for LS-6000 - B108451POSCAEL2MUS00

No Description
BTL INDUSTRIES LIMITED
Scanning System for LS-6000
In Commercial Distribution

  • B108451POSCAEL2MUS00 ()


  • Skin laser scanner

LS-6000 - B108043PO30WMUS00

No Description
BTL INDUSTRIES LIMITED
LS-6000
In Commercial Distribution

  • B108043PO30WMUS00 ()


  • Red-light phototherapy unit, professional

TDP CQ-55A Heat Lamp - 16970469760047

The TDP CQ-55A heat lamp is unlike any other heat lamp. While most lamps use a common infrared bulb, the specially engineered TDP CQ-55A features a "black body" emission heating plate which is coated with a proprietary mineral formulation consisting of 33 elements. When activated by a built-in electric heating element, this mineral plate emits a special band of far infrared electromagnetic energy which penetrates deep into the human body. The human body (cells) has a higher absorption efficiency for far infrared energy than near infrared. The emission head can be positioned as low as 12" (for treating feet) to 60". Depending on the treated condition, repeated treatments of 20 to 40 minutes are recommended. Easy assembly. Floor model, 5-point base with casters. UL approved. Has continuous ON or 60-minute timer. Treatment distance is 8” to 18” (20 to 46 cm). Main post telescopes 12”; device head tilts up to 90 degrees and rotates 360 degrees. Warranty: 90 days (parts and labor), 1 year(parts)
CHONGQING XINFENG MEDICAL INSTRUMENTS CO., LTD.
RY3847
In Commercial Distribution

  • 16970469760047 ()

  • Range: 24" vertical, 24" horizontal Min/Max Height: 23" to 60" above floor
  • Weight: 25 Pound
RY3847

  • Musculoskeletal infrared phototherapy unit, non-wearable

TDP CQ-55 Heat Lamp - 16970469760030

The TDP CQ-55 heat lamp is unlike any other heat lamp. While most lamps use a common infrared bulb, the specially engineered TDP CQ-55 features a "black body" emission heating plate which is coated with a proprietary mineral formulation consisting of 33 elements. When activated by a built-in electric heating element, this mineral plate emits a special band of far infrared electromagnetic energy which penetrates deep into the human body. The human body (cells) has a higher absorption efficiency for far infrared energy than near infrared. The emission head can be positioned as low as 12" (for treating feet) to 60". Depending on the treated condition, repeated treatments of 20 to 40 minutes are recommended. Easy assembly. Floor model, 5-point base with casters. UL approved. Has continuous ON or 60-minute timer. Treatment distance is 8” to 18” (20 to 46 cm). Main post telescopes 12”; device head tilts up to 90 degrees and rotates 360 degrees. Warranty: 90 days (parts and labor), 1 year(parts)
CHONGQING XINFENG MEDICAL INSTRUMENTS CO., LTD.
RY3935
In Commercial Distribution

  • 16970469760030 ()

  • Weight: 25 Pound
  • Range: 24" vertical, 24" horizontal Min/Max Height: 23" to 60" above floor
RY3935

  • Musculoskeletal infrared phototherapy unit, non-wearable

TDP CQ-36 Heat Lamp - 16970469760023

The TDP CQ-36 heat lamp is unlike any other heat lamp. While most lamps use a common infrared bulb, the specially engineered TDP CQ-36 features a "black body" emission heating plate which is coated with a proprietary mineral formulation consisting of 33 elements. When activated by a built-in electric heating element, this mineral plate emits a special band of far infrared electromagnetic energy which penetrates deep into the human body. The human body (cells) has a higher absorption efficiency for far infrared energy than near infrared. The emission head can be positioned as low as 12" (for treating feet) to 60". Depending on the treated condition, repeated treatments of 20 to 40 minutes are recommended. Easy assembly. Floor model, 5-point base with casters. UL approved. Has continuous ON or 60-minute timer. Treatment distance is 8” to 18” (20 to 46 cm). Main post telescopes 12”; device head tilts up to 90 degrees and rotates 360 degrees. Warranty: 90 days (parts and labor), 1 year(parts)
CHONGQING XINFENG MEDICAL INSTRUMENTS CO., LTD.
RY3899
In Commercial Distribution

  • 16970469760023 ()

  • Range: 24" vertical, 24" horizontal Min/Max Height: 23" to 60" above floor
  • Weight: 25 Pound
RY3899

  • Musculoskeletal infrared phototherapy unit, non-wearable

TDP CQ-27 Heat Lamp - 16970469760016

The TDP CQ-27 heat lamp is unlike any other heat lamp. While most lamps use a common infrared bulb, the specially engineered TDP CQ-36 features a "black body" emission heating plate which is coated with a proprietary mineral formulation consisting of 33 elements. When activated by a built-in electric heating element, this mineral plate emits a special band of far infrared electromagnetic energy which penetrates deep into the human body. The human body (cells) has a higher absorption efficiency for far infrared energy than near infrared. The emission head can be positioned as low as 12" (for treating feet) to 60". Depending on the treated condition, repeated treatments of 20 to 40 minutes are recommended. Easy assembly. Floor model, 5-point base with casters. UL approved. Has continuous ON or 60-minute timer. Treatment distance is 8” to 18” (20 to 46 cm). Main post telescopes 12”; device head tilts up to 90 degrees and rotates 360 degrees. Warranty: 90 days (parts and labor), 1 year(parts)
CHONGQING XINFENG MEDICAL INSTRUMENTS CO., LTD.
RY3364
In Commercial Distribution

  • 16970469760016 ()

  • Weight: 25 Pound
  • Range: 24" vertical, 24" horizontal Min/Max Height: 12" to 60" above floor
RY3364

  • Musculoskeletal infrared phototherapy unit, non-wearable

Lumaflex - 06970006971649

The Lumaflex Panel (Model: ZLD-05A) is intended to deliver heat in the red and infrared spectrum to provide topical heating for the purpose of elevating tissue temperature; for the temporary relief of minor muscle and joint pain, arthritis and muscle spasm; relieving stiffness; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation. CLOSE
Shenzhen Kaiyan Medical Equipment Co,. Ltd
ZLD-05A
In Commercial Distribution

  • 06970006971649 ()


  • Red/infrared light phototherapy unit

Lumaflex - 06970006971038

The Lumaflex Panel (Model: ZLD-05) is intended to deliver heat in the red and infrared spectrum to provide topical heating for the purpose of elevating tissue temperature; for the temporary relief of minor muscle and joint pain, arthritis and muscle spasm; relieving stiffness; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation.
Shenzhen Kaiyan Medical Equipment Co,. Ltd
ZLD-05
In Commercial Distribution

  • 06970006971038 ()


  • Red/infrared light phototherapy unit

Cofoe - 06950715501054

No Description
Cofoe Medical Technology Co.,Ltd
KF-29
Not in Commercial Distribution

  • 06950715501054 ()


  • Blue/red/infrared phototherapy lamp

Bashan - 06970567470162

Bashan TDP Heat Lamp, including TDP-124D/166D and TDP-124F/166F, is an infrared lamp that emits the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature, to temporarily increase local blood circulation, and to temporarily relieve minor muscle and joint pain and stiffness. The lamps may also help minor muscular back pain.
Chongqing Yuhe Medical Instruments Co., Ltd.
TDP-124D,TDP-166D
In Commercial Distribution

  • 06970567470162 ()


  • Musculoskeletal infrared phototherapy unit, non-wearable

ZONN - 06975188960139

This product is a far-infrared penetration instrument, which mainly provides topical heating of the head to increase tissue temperature, and to adjust head massage mode, promoting scalp tissue relaxation, and temporarily increasing local blood circulation.
Zonnsmart Science & Technology Co.,Ltd
HL711 PRO MAX
In Commercial Distribution

  • 06975188961136 ()
  • 06975188960139 ()


  • Red/infrared light phototherapy unit

ZONN - 06975188960115

This product is a far-infrared penetration instrument, which mainly provides topical heating of the head to increase tissue temperature, and to adjust head massage mode, promoting scalp tissue relaxation, and temporarily increasing local blood circulation.
Zonnsmart Science & Technology Co.,Ltd
HL811 PRO MAX
In Commercial Distribution

  • 06975188961112 ()
  • 06975188960115 ()


  • Red/infrared light phototherapy unit

ZONN - 06975188960108

This product is a far-infrared penetration instrument, which mainly provides topical heating of the head to increase tissue temperature, and to adjust head massage mode, promoting scalp tissue relaxation, and temporarily increasing local blood circulation.
Zonnsmart Science & Technology Co.,Ltd
HL800 PRO
In Commercial Distribution

  • 06975188961105 ()
  • 06975188960108 ()


  • Red/infrared light phototherapy unit

ZONN - 06975188960085

This product is a far-infrared penetration instrument, which mainly provides topical heating of the head to increase tissue temperature, and to adjust head massage mode, promoting scalp tissue relaxation, and temporarily increasing local blood circulation.
Zonnsmart Science & Technology Co.,Ltd
HL850 PRO
In Commercial Distribution

  • 06975188961082 ()
  • 06975188960085 ()


  • Red/infrared light phototherapy unit

ZONN - 06975188960061

This product is a far-infrared penetration instrument, which mainly provides topical heating of the head to increase tissue temperature, and to adjust head massage mode, promoting scalp tissue relaxation, and temporarily increasing local blood circulation.
Zonnsmart Science & Technology Co.,Ltd
HL700 PRO
In Commercial Distribution

  • 06975188961068 ()
  • 06975188960061 ()


  • Red/infrared light phototherapy unit

ZONN - 06975188960054

This product is a far-infrared penetration instrument, which mainly provides topical heating of the head to increase tissue temperature, and to adjust head massage mode, promoting scalp tissue relaxation, and temporarily increasing local blood circulation.
Zonnsmart Science & Technology Co.,Ltd
HL700 PRO MAX
In Commercial Distribution

  • 06975188960054 ()
  • 06975188961051 ()


  • Red/infrared light phototherapy unit

ZONN - 06975188960047

This product is a far-infrared penetration instrument, which mainly provides topical heating of the head to increase tissue temperature, and to adjust head massage mode, promoting scalp tissue relaxation, and temporarily increasing local blood circulation.
Zonnsmart Science & Technology Co.,Ltd
BR01
In Commercial Distribution

  • 06975188961044 ()
  • 06975188960047 ()


  • Red/infrared light phototherapy unit

sgrow LED Therapy Light - 06976006410010

No Description
Shenzhen Sungrow LED Technology Co., LTD
E2400
In Commercial Distribution

  • 06976006410010 ()


  • Blue/red/infrared phototherapy lamp
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