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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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Led Light Phototherapy Bed - 06973337184504

No Description
Shenzhen Suyzeko Limited
Pro450
In Commercial Distribution

  • 06973337184504 ()


  • Red/infrared light phototherapy unit

Laserconn - 06972558160021

Diode laser is intended to provide topical heating for the purpose of elevating tissue temperature for temporary relief of muscle and joint pain and stiffness, temporary increase local blood circulation and promoting relaxation of muscle
Sanhe Laserconn Tech Co., Ltd.
Theralas
In Commercial Distribution

  • 16972558160028 ()
  • 06972558160021 ()

  • Length: 462.50 Micrometer
  • Width: 368.00 Micrometer
  • Height: 264.58 Micrometer
Laser Therapy System

  • Musculoskeletal/physical therapy laser, professional

ideainfrared - 06974958310082

LED Red Therapy Light
Shenzhen Idea Light Limited
RL60S
In Commercial Distribution

  • 06974958310082 ()


  • Red/infrared light phototherapy unit
  • Cosmetic red-light phototherapy system, home-use

ideainfrared - 06974958310044

Portable red light therapy
Shenzhen Idea Light Limited
RTL12C
In Commercial Distribution

  • 06974958310044 ()


  • Red/infrared light phototherapy unit
  • Cosmetic red-light phototherapy system, home-use

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

Bashan - 06970567470155

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-124F,TDP-166F
In Commercial Distribution

  • 06970567470155 ()


  • Musculoskeletal infrared phototherapy unit, non-wearable

Cabpay - 06975850450562

No Description
Shenzhen Yihong Lighting Co., Ltd.
YD056
In Commercial Distribution

  • 06975850450562 ()


  • Blue/red/infrared phototherapy lamp

Cabpay - 06975850450159

No Description
Shenzhen Yihong Lighting Co., Ltd.
YD015
In Commercial Distribution

  • 06975850450159 ()


  • Blue/red/infrared phototherapy lamp

Cabpay - 06975850450036

No Description
Shenzhen Yihong Lighting Co., Ltd.
YD003
In Commercial Distribution

  • 06975850450036 ()


  • Blue/red/infrared phototherapy lamp

Yihong - 06975850450012

No Description
Shenzhen Yihong Lighting Co., Ltd.
YD001
In Commercial Distribution

  • 06975850450012 ()


  • Blue/red/infrared phototherapy lamp

sgrow LED Therapy Light - 06976006410010

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

  • 06976006410010 ()


  • Blue/red/infrared phototherapy lamp

Redfy - 06975981280014

No Description
SunPlus LED Technology Co., Ltd.
RD2000
In Commercial Distribution

  • 06975981280014 ()


  • Cosmetic red-light phototherapy system, home-use

SPORTSMAX - 06975965182020

No Description
Ningbo Yimei Nikko-seiki Manufacture Co.,LTD
TN2428
Not in Commercial Distribution

  • 06975965182020 ()


  • Blue/red/infrared phototherapy lamp

TOUCHBEAUTY - 06971024921258

Portable LED facial device
TOUCHBEAUTY BEAUTY & HEALTH (SHENZHEN) CO., LTD
TB-1696B
In Commercial Distribution

  • 06971024921258 ()


  • Blue/red/infrared phototherapy lamp

TOUCHBEAUTY - 06971024921135

No Description
TOUCHBEAUTY BEAUTY & HEALTH (SHENZHEN) CO., LTD
TB-1611B
In Commercial Distribution

  • 06971024921135 ()


  • Blue/red/infrared phototherapy lamp

Touch beauty - 06971024921128

No Description
TOUCHBEAUTY BEAUTY & HEALTH (SHENZHEN) CO., LTD
TB-1611A
In Commercial Distribution

  • 06971024921128 ()


  • Blue/red/infrared phototherapy lamp

TOUCHBEAUTY - 06971024921265

Eyes beauty device
TOUCHBEAUTY BEAUTY & HEALTH (SHENZHEN) CO., LTD
TB-1980K
In Commercial Distribution

  • 06971024921265 ()


  • Blue/red/infrared phototherapy lamp

TOUCHBEAUTY - 06971024921241

No Description
TOUCHBEAUTY BEAUTY & HEALTH (SHENZHEN) CO., LTD
TB-1696A
In Commercial Distribution

  • 06971024921241 ()


  • Blue/red/infrared phototherapy lamp

Touchbeauty - 06971024920008

No Description
TOUCHBEAUTY BEAUTY & HEALTH (SHENZHEN) CO., LTD
TB-1767
In Commercial Distribution

  • 06971024920008 ()


  • Blue/red/infrared phototherapy lamp

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

ZONN - 06975188960146

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
In Commercial Distribution

  • 06975188961143 ()
  • 06975188960146 ()


  • Red/infrared light phototherapy unit

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 - 06975188960122

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
In Commercial Distribution

  • 06975188961129 ()
  • 06975188960122 ()


  • 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 - 06975188960092

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
HL880 PRO MAX
In Commercial Distribution

  • 06975188961099 ()
  • 06975188960092 ()


  • 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 - 06975188960078

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 MAX
In Commercial Distribution

  • 06975188961075 ()
  • 06975188960078 ()


  • 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

ZONN - 06975188960030

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-MA
In Commercial Distribution

  • 06975188961037 ()
  • 06975188960030 ()


  • Red/infrared light phototherapy unit

ZONN - 06975188960023

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-BT
In Commercial Distribution

  • 06975188961020 ()
  • 06975188960023 ()


  • Red/infrared light phototherapy unit

ZONN - 06975188960016

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
In Commercial Distribution

  • 06975188961013 ()
  • 06975188960016 ()


  • 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

Main Controller Unit I Professional (MCU I-P) - B271MCUIP0

No Description
Meditech International Inc
MCU I-P
In Commercial Distribution

  • B271MCUIP0 ()


  • Red-light phototherapy unit, professional

Main Controller Unit I Home (MCU I-H) - B271MCUIH0

No Description
Meditech International Inc
MCU I-H
In Commercial Distribution

  • B271MCUIH0 ()


  • Red-light phototherapy unit, professional

Sharper Image - 00840397513390

No Description
Merchsource, LLC
1019359
In Commercial Distribution

  • 00840397513390 ()


  • Red/infrared light phototherapy unit

Ovation - 00860009854529

The OvationULT is an over-the-counter device that utilizes LED diodes to emit energy in the visible and IR spectrum intended to provide topical heating for the purpose of elevating tissue temperature for a temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain or muscle spasm, the temporary increase in local blood circulation, and the temporary relaxation of muscles.
Body Balance System, LLC
ULT
In Commercial Distribution

  • 00860009854529 ()


  • Red/infrared light phototherapy unit

660nm 75mW Red Light Guide Laser - 05060494130626

S2173 660nm 75mW Red Light Guide Laser
THOR PHOTOMEDICINE LIMITED
1.0
In Commercial Distribution

  • 05060494130626 ()


  • Red-light phototherapy unit, professional

810nm 200mW NIR Light Guide Laser - 05060494130619

S2091 810nm 200mW NIR Light Guide Laser
THOR PHOTOMEDICINE LIMITED
2.0
In Commercial Distribution

  • 05060494130619 ()


  • Red-light phototherapy unit, professional

Veridian Healthcare - 00845717007931

TENS unit with heat and conductive heating knee wrap
VERIDIAN HEALTHCARE LLC
22-033KW
In Commercial Distribution

  • 00845717007931 ()
22-033KW

  • Physical therapy transcutaneous neuromuscular electrical stimulation system

Veridian Healthcare - 00845717007917

Conductive Heating Knee Wrap for model 22-033 TENS unit
VERIDIAN HEALTHCARE LLC
22-050
In Commercial Distribution

  • 00845717007917 ()
22-050

  • Physical therapy transcutaneous neuromuscular electrical stimulation system

MED2975 - 00851962007671

18.5 cu ft zone heating blanket and fluid warmer
ENTHERMICS, INC.
MED2975
In Commercial Distribution

  • 00851962007671 ()


  • Multi-purpose warming cabinet, stationary

MED2275 - 00851962007664

13.5 cu ft zone heating blanket and fluid warmer
ENTHERMICS, INC.
MED2275
In Commercial Distribution

  • 00851962007664 ()


  • Multi-purpose warming cabinet, stationary

One Degree Medical - 00860003583050

3.8L Capacity Fluid Warming Unit - ODM-3038
ONE DEGREE MEDICAL HOLDINGS, LLC
ODM-3038
In Commercial Distribution

  • 00860003583050 ()


  • Surgical fluid heating plate

One Degree Medical - 00860003583043

6.6L Capacity Fluid Warming Unit - ODM-3066
ONE DEGREE MEDICAL HOLDINGS, LLC
ODM-3066
In Commercial Distribution

  • 00860003583043 ()


  • Surgical fluid heating plate

Halyard - 10680651517439

HYH,WARMER,FLUID,6.6L,1
Avanos Medical, Inc.
51743
In Commercial Distribution

  • 30680651517433 ()
  • 10680651517439 ()
51743

  • Surgical fluid heating plate

Halyard - 10680651517422

HYH,WARMER,FLUID,3.8L,1
Avanos Medical, Inc.
51742
In Commercial Distribution

  • 30680651517426 ()
  • 10680651517422 ()
51742

  • Surgical fluid heating plate
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