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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Brand Name: LD-R 100+ Model Number: LD-R 100+
Meditech International Inc
LD-R 100+
In Commercial Distribution

  • B271LDR100P0 ()


  • Red-light phototherapy unit, professional
No Description
Meditech International Inc
LD-R 100
In Commercial Distribution

  • B271LDR1000 ()


  • Red-light phototherapy unit, professional
No Description
Meditech International Inc
LS-B 3000
In Commercial Distribution

  • B271DUO2400 ()


  • Red-light phototherapy unit, professional
No Description
Meditech International Inc
LS-B 2250
In Commercial Distribution

  • B271DUO1800 ()


  • Red-light phototherapy unit, professional
No Description
Meditech International Inc
CU+A
In Commercial Distribution

  • B271CUPA0 ()


  • Red-light phototherapy unit, professional
No Description
Meditech International Inc
CU+
In Commercial Distribution

  • B271CUP0 ()


  • Red-light phototherapy unit, professional
No Description
Meditech International Inc
CU
In Commercial Distribution

  • B271CU0 ()


  • Red-light phototherapy unit, professional
No Description
Meditech International Inc
SLD+ 180A
In Commercial Distribution

  • B271ART1800 ()


  • Red-light phototherapy unit, professional
Far Infra Red photo therapy unit indicated for pain relief and to increase local circulation. It utilizes thermal far infra-red therapeutic heating, therapeutic manual massage, and is approved for relief of muscle and joint pain and stiffness, muscle relaxation, temporary increase in circulation and for temporary arthritis pain relief.
MIGUN LIFE INC
HY777
In Commercial Distribution

  • B344HY7770 ()


  • Musculoskeletal infrared phototherapy unit, non-wearable
Model 70800 XINFENG Heat Lamp is made from a famous heat lamp manufacturer in China. Floor Type Style Lamp is contents a replaceable heads with digital controller. it's a durable and safety lamp with 5 plastic legs base. Sold by Each.
HEALTH BODY WORLD SUPPLY, INC.
70800
In Commercial Distribution

  • 00816073022654 ()
70800

  • Musculoskeletal infrared phototherapy unit, non-wearable
Model 70400 XINFENG Heat Lamp is made from a famous heat lamp manufacturer in China. Floor Type Style Lamp is contents a replaceable heads with manual controller it's a durable and safety lamp with 5 plastic legs base. Sold by Each.
HEALTH BODY WORLD SUPPLY, INC.
70400
In Commercial Distribution

  • 00816073022647 ()
70400

  • Musculoskeletal infrared phototherapy unit, non-wearable
Model 27029 XINFENG TDP Lamp 5" Head. Sold by Each.
HEALTH BODY WORLD SUPPLY, INC.
27027
In Commercial Distribution

  • 00816073022388 ()
27027

  • Musculoskeletal infrared phototherapy unit, non-wearable
Model 27029 XINFENG TDP Lamp 7" Head. Sold by Each.
HEALTH BODY WORLD SUPPLY, INC.
27029
In Commercial Distribution

  • 00816073022371 ()
27029

  • Musculoskeletal infrared phototherapy unit, non-wearable
Model 70058 XINFENG TDP Lamp is made from a famous tdp lamp manufacturer in China. Floor Type Style Lamp is contends a single jumbo head with digital controller. it's a durable and safety lamp with 5 Metal legs base plus 1 lockable wheel. This lamp was certificated FDA, CE, ISO and UL. Included 2 fuse and instruction menu. Sold by Each.
HEALTH BODY WORLD SUPPLY, INC.
70058
In Commercial Distribution

  • 00816073020308 ()
70058

  • Musculoskeletal infrared phototherapy unit, non-wearable
Model 70032 XINFENG TDP Lamp is made from a famous tdp lamp manufacturer in China. Floor Type Style Lamp is contents 2 replaceable large (6.75") heads with 2 individual digital controllers. it's a durable and safety lamp with 5 metal legs base with 1 lockable wheel. This lamp is certificated FDA, CE, ISO and UL. Included 2 fuse and instruction menu. Sold by Each.
HEALTH BODY WORLD SUPPLY, INC.
70032
In Commercial Distribution

  • 00816073020070 ()
70032

  • Musculoskeletal infrared phototherapy unit, non-wearable
Model 70036 XINFENG TDP Lamp is made from a famous tdp lamp manufacturer in China. Floor Type Style Lamp is contents 2 replaceable large (6.75") heads with 2 individual manual controllers. it's a durable and safety lamp with 5 metal legs base with 1 lockable wheel. This lamp is certificated FDA, CE, ISO and UL. Included 2 fuse and instruction menu. Sold by Each.
HEALTH BODY WORLD SUPPLY, INC.
70036
In Commercial Distribution

  • 00816073020049 ()
70036

  • Musculoskeletal infrared phototherapy unit, non-wearable
Model 70055 XINFENG TDP Lamp is made from a famous tdp lamp manufacturer in China. Contents single replaceable large (6.75") heads with digital controller. it's a durable and safety lamp with 5 Metal legs base with 2 lockable wheels. This lamp was certificated FDA, CE, ISO and UL. Included 2 fuse and instruction menu. Sold by Each.
HEALTH BODY WORLD SUPPLY, INC.
70055
In Commercial Distribution

  • 00816073020032 ()
70055

  • Musculoskeletal infrared phototherapy unit, non-wearable
Model 70027 XINFENG TDP Lamp is made from a famous tdp lamp manufacturer in China. Floor Type Style Lamp is contents single replaceable small (4.75") head with manual controller, it's a deluxe and durable lamp with 5 of unbreakable ABS plastic legs base. This lamp was certificated FDA, CE, ISO and UL. Included 2 fuse and instruction menu. Sold by Each.
HEALTH BODY WORLD SUPPLY, INC.
70027
In Commercial Distribution

  • 00816073020025 ()
70027

  • Musculoskeletal infrared phototherapy unit, non-wearable
Model 70029 XINFENG TDP Lamp is made from a famous tdp lamp manufacturer in China. Floor Type Style Lamp is contents a single replaceable large (6.75") head with manual controller. it's a durable and safety lamp with 5 Metal legs base with 2 lockable wheels. This lamp was certificated FDA, CE, ISO and UL. Included 2 fuse and instruction menu. Sold by Each.
HEALTH BODY WORLD SUPPLY, INC.
70029
In Commercial Distribution

  • 00816073020018 ()
70029

  • Musculoskeletal infrared phototherapy unit, non-wearable
Model 70012 XINFENG TDP Lamp is made from a famous tdp lamp manufacturer in China. Desk-Top style lamp contents a single replaceable small (4.75") head with manual controller. Lightweight to easy carry to anywhere. This lamp was certificated FDA, CE, ISO and UL. Included 2 fuse and instruction menu. Sold by Each.
HEALTH BODY WORLD SUPPLY, INC.
70012
In Commercial Distribution

  • 00816073020001 ()
70012

  • Musculoskeletal infrared phototherapy unit, non-wearable
BodyMed Fingertip Pulse Oximeter, red LED display, 2 AAA batteries included
BOXOUT, LLC
BDMPULSEOX
In Commercial Distribution

  • 20815991025185 ()
  • 00815991025181 ()
BDMPULSEOX

  • Pulse oximeter
No Description
BOXOUT, LLC
BDMOXMTRBLK
In Commercial Distribution

  • 20815991022634 ()
  • 00815991022630 ()
BDMOXMTRBLK

  • Pulse oximeter
No Description
BTL INDUSTRIES LIMITED
LS-6000
In Commercial Distribution

  • B108043PO30WMUS00 ()


  • Red-light phototherapy unit, professional
No Description
BTL INDUSTRIES LIMITED
Scanning System for LS-6000
In Commercial Distribution

  • B108451POSCAEL2MUS00 ()


  • Skin laser scanner
Finger Pulse Oximeter, OTC
COMPASS HEALTH BRANDS CORP.
50052
Not in Commercial Distribution

  • 00092237604595 ()
  • 30815067013372 ()
  • 00815067013371 ()


  • Pulse oximeter probe, reusable
No Description
Weber Medical GmbH
weberneedleĀ® basic "compact edition" laser
In Commercial Distribution

  • B45510551 ()


  • Musculoskeletal infrared phototherapy unit, non-wearable
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
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
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
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
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
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
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
The PHYSIQ is a system provided with 4 IR LED to provide topical heating for the purpose of elevating tissue temperature for temporary relief of muscles. A LED mounted on top of each handpiece is lighted when the handpiece is emitting.
EL.EN. SPA
M120F1
In Commercial Distribution

  • 08057017760498 ()
M120F1

  • Musculoskeletal infrared phototherapy unit, non-wearable
The ASA LASER HIRO 3.0 device is a medical device for carrying out therapy in the treatment of musculotendinous and joint pathologies with Nd:YAG Laser source.
EL.EN. SPA
M080K1
In Commercial Distribution

  • 08057017760214 ()
M080K1

  • Musculoskeletal infrared phototherapy unit, non-wearable
The ASA LASER SH1 device is a medical device for carrying out therapy in the treatment of musculotendinous and joint pathologies with Nd:YAG laser sources.
EL.EN. SPA
M077H3
In Commercial Distribution

  • 08057017760207 ()
M077H3

  • Musculoskeletal infrared phototherapy unit, non-wearable
LASER THERAPY UNIT LUMIX 2 TOUCH SCREEN with 2 WAVELENGTH (650nm+910nm)
FISIOLINE SRL
LUMIX CPS
In Commercial Distribution

  • 08057949171911 ()

  • Lumen/Inner Diameter: 910 Nanometer
  • Lumen/Inner Diameter: 650 Nanometer
  • Lumen/Inner Diameter: 10 Millimeter
LUMIXCPS2HP

  • Skin laser scanner
LASER THERAPY UNIT LUMIX 250 TOUCH SCREEN with 2 WAVELENGTH (650nm+910nm) AVERAGE POWER 5W
FISIOLINE SRL
LUMIX 250
In Commercial Distribution

  • 08057949171850 ()

  • Lumen/Inner Diameter: 20 Millimeter
  • Lumen/Inner Diameter: 910 Nanometer
  • Lumen/Inner Diameter: 650 Nanometer
LUMIX250R3

  • Skin laser scanner
LASER THERAPY UNIT LUMIX 100 TOUCH SCREEN with 2 WAVELENGTH (650nm+910nm) AVERAGE POWER 2W
FISIOLINE SRL
LUMIX 100
In Commercial Distribution

  • 08057949171843 ()

  • Lumen/Inner Diameter: 910 Nanometer
  • Lumen/Inner Diameter: 650 Nanometer
  • Lumen/Inner Diameter: 20 Millimeter
LUMIX100R3

  • Skin laser scanner
LASER THERAPY UNIT LUMIX ULTRA/PLUS with 5 WAVELENGTH (650nm+810nm+910nm+980nm+1064nm)
FISIOLINE SRL
LUMIX ULTRA 2
In Commercial Distribution

  • 08057949171782 ()

  • Lumen/Inner Diameter: 20 Millimeter
  • Lumen/Inner Diameter: 650 Nanometer
  • Lumen/Inner Diameter: 810 Nanometer
  • Lumen/Inner Diameter: 910 Nanometer
  • Lumen/Inner Diameter: 980 Nanometer
  • Lumen/Inner Diameter: 1064 Nanometer
LULTRA33HP

  • Skin laser scanner
LASER THERAPY UNIT LUMIX ULTRA/PLUS with 5 WAVELENGTH (650nm+810nm+910nm+980nm+1064nm)
FISIOLINE SRL
LUMIX ULTRA 2
In Commercial Distribution

  • 08057949171775 ()

  • Lumen/Inner Diameter: 20 Millimeter
  • Lumen/Inner Diameter: 650 Nanometer
  • Lumen/Inner Diameter: 810 Nanometer
  • Lumen/Inner Diameter: 910 Nanometer
  • Lumen/Inner Diameter: 980 Nanometer
  • Lumen/Inner Diameter: 1064 Nanometer
LULTRA33

  • Skin laser scanner
LASER THERAPY UNIT LUMIX ULTRA/PLUS with 5 WAVELENGTH (650nm+810nm+910nm+980nm+1064nm)
FISIOLINE SRL
LUMIX ULTRA 2
In Commercial Distribution

  • 08057949171768 ()

  • Lumen/Inner Diameter: 20 Millimeter
  • Lumen/Inner Diameter: 650 Nanometer
  • Lumen/Inner Diameter: 810 Nanometer
  • Lumen/Inner Diameter: 910 Nanometer
  • Lumen/Inner Diameter: 980 Nanometer
  • Lumen/Inner Diameter: 1064 Nanometer
LPLUS30HP

  • Skin laser scanner
LASER THERAPY UNIT LUMIX ULTRA/PLUS with 5 WAVELENGTH (650nm+810nm+910nm+980nm+1064nm)
FISIOLINE SRL
LUMIX ULTRA 2
In Commercial Distribution

  • 08057949171751 ()

  • Lumen/Inner Diameter: 20 Millimeter
  • Lumen/Inner Diameter: 650 Nanometer
  • Lumen/Inner Diameter: 810 Nanometer
  • Lumen/Inner Diameter: 910 Nanometer
  • Lumen/Inner Diameter: 980 Nanometer
  • Lumen/Inner Diameter: 1064 Nanometer
LPLUS30

  • Skin laser scanner
LASER THERAPY UNIT LUMIX C.P.S with 5 WAVELENGTH (650nm+810nm+910nm+980nm+1064nm)
FISIOLINE SRL
LUMIX C.P.S. 5
In Commercial Distribution

  • 08057949171690 ()

  • Lumen/Inner Diameter: 10 Millimeter
  • Lumen/Inner Diameter: 650 Nanometer
  • Lumen/Inner Diameter: 810 Nanometer
  • Lumen/Inner Diameter: 980 Nanometer
  • Lumen/Inner Diameter: 1064 Nanometer
  • Lumen/Inner Diameter: 910 Nanometer
LCPS29

  • Skin laser scanner
LASER THERAPY UNIT LUMIX Q with 2 WAVELENGTH (650nm+1064nm)
FISIOLINE SRL
LUMIX C.P.S. 3
In Commercial Distribution

  • 08057949171645 ()

  • Lumen/Inner Diameter: 10 Millimeter
  • Lumen/Inner Diameter: 650 Nanometer
  • Lumen/Inner Diameter: 1064 Nanometer
LUMIXQ01

  • Skin laser scanner
LASER THERAPY UNIT LUMIX ULTRA/PLUS with 4 WAVELENGTH (650nm+810nm+910nm+980nm)
FISIOLINE SRL
LUMIX ULTRA 3
In Commercial Distribution

  • 08057949171638 ()

  • Lumen/Inner Diameter: 20 Millimeter
  • Lumen/Inner Diameter: 980 Nanometer
  • Lumen/Inner Diameter: 910 Nanometer
  • Lumen/Inner Diameter: 810 Nanometer
  • Lumen/Inner Diameter: 650 Nanometer
LPLUS1602HP

  • Skin laser scanner
LASER THERAPY UNIT LUMIX ULTRA/PLUS with 4 WAVELENGTH (650nm+810nm+910nm+1064nm)
FISIOLINE SRL
LUMIX ULTRA 2
In Commercial Distribution

  • 08057949171621 ()

  • Lumen/Inner Diameter: 20 Millimeter
  • Lumen/Inner Diameter: 1064 Nanometer
  • Lumen/Inner Diameter: 910 Nanometer
  • Lumen/Inner Diameter: 810 Nanometer
  • Lumen/Inner Diameter: 650 Nanometer
LPLUS1601HP

  • Skin laser scanner
LASER THERAPY UNIT LUMIX ULTRA/PLUS with 3 WAVELENGTH (650nm+910mn+1064nm)
FISIOLINE SRL
LUMIX ULTRA 1
In Commercial Distribution

  • 08057949171614 ()

  • Lumen/Inner Diameter: 20 Millimeter
  • Lumen/Inner Diameter: 1064 Nanometer
  • Lumen/Inner Diameter: 910 Nanometer
  • Lumen/Inner Diameter: 650 Nanometer
LPLUS13HP

  • Skin laser scanner
LASER THERAPY UNIT LUMIX ULTRA/PLUS with 3 WAVELENGTH (650nm+910nm+980nm)
FISIOLINE SRL
LUMIX ULTRA 3
In Commercial Distribution

  • 08057949171607 ()

  • Lumen/Inner Diameter: 20 Millimeter
  • Lumen/Inner Diameter: 980 Nanometer
  • Lumen/Inner Diameter: 910 Nanometer
  • Lumen/Inner Diameter: 650 Nanometer
LPLUS1002HP

  • Skin laser scanner
LASER THERAPY UNIT LUMIX ULTRA/PLUS with 3 WAVELENGTH (650nm+910nm+1064nm)
FISIOLINE SRL
LUMIX ULTRA 1
In Commercial Distribution

  • 08057949171591 ()

  • Lumen/Inner Diameter: 20 Millimeter
  • Lumen/Inner Diameter: 1064 Nanometer
  • Lumen/Inner Diameter: 910 Nanometer
  • Lumen/Inner Diameter: 650 Nanometer
LPLUS1001HP

  • Skin laser scanner
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