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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 Glove Device- Omnilux Contour Branded
I-SMART DEVELOPMENTS LIMITED
TN19S
In Commercial Distribution

  • 05060534510210 ()
125A

  • Red/infrared light phototherapy unit
LED Décolletage & Neck Device-Opatra Branded
I-SMART DEVELOPMENTS LIMITED
TN2037
In Commercial Distribution

  • 05060534510203 ()
112A

  • Cosmetic red-light phototherapy system, home-use
Décolletage & Neck Device- Currentbody Skin Branded
I-SMART DEVELOPMENTS LIMITED
TN2037
Not in Commercial Distribution

  • 05060534510142 ()
112A

  • Cosmetic red-light phototherapy system, home-use
LED Neck & Décolletage Device- Omnilux Contour Branded
I-SMART DEVELOPMENTS LIMITED
TN2037
In Commercial Distribution

  • 05060534510135 ()
112A

  • Cosmetic red-light phototherapy system, home-use
LED Décolletage & Neck Device- DP Dermaceuticals Branded
I-SMART DEVELOPMENTS LIMITED
TN2037
In Commercial Distribution

  • 05060534510111 ()
112A

  • Cosmetic red-light phototherapy system, home-use
Décolletage & Neck Device- decoLITE Branded
I-SMART DEVELOPMENTS LIMITED
TN2037
In Commercial Distribution

  • 05060534510036 ()
112A

  • Cosmetic red-light phototherapy system, home-use
a cosmetic outlook improved version if compare with the previous ABPT1003 device. so, this is a Mark II version with slight change to the machine outlook.
APPLIED BIOPHOTONICS LIMITED
ABPT1003-2
In Commercial Distribution

  • 04719873240029 ()


  • Red-light phototherapy unit, professional
  • Musculoskeletal infrared phototherapy unit, non-wearable
No Description
APPLIED BIOPHOTONICS LIMITED
ABPT1003
In Commercial Distribution

  • 04719873240012 ()


  • Red-light phototherapy unit, professional
  • Musculoskeletal infrared phototherapy unit, non-wearable
The WS Far-Infrared Therapy Unit, Model: KP-B210, is an infrared heating system which delivers 3~25 μm Far-infrared energy through Far Infrared (FIR) radiation plate. The device is a non-invasive physiology therapy device and emits topical heat to the human forearm and upper arm for therapeutic applications without direct contact. The model, KP-B210 is a single object without additional assembly which contains an emitter, a user control panel, a power switch and safety distance reminder.
WS FAR IR MEDICAL TECHNOLOGY CO., LTD.
KP-B210
In Commercial Distribution

  • 04719873220199 ()


  • Full-body radiant heating system
The WS Therapy Unit is an infrared heating system which emits topical heat to the human body for therapeutic applications. It consists of an IR emitter (Emission spectrum ranges from 3~25 microns.), a control box, a supporting arm to allow for adjustment of the emitter locations, and a protection net on the emitter to prevent fire or direct touch by the user. The entire unit is mounted on the base that is easy to move. The device uses 100V as the power source. It meets the related requirement of IEC60601-1 Electrical Safety.
WS FAR IR MEDICAL TECHNOLOGY CO., LTD.
TY-101F
In Commercial Distribution

  • 04719873220045 ()


  • Full-body radiant heating system
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