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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No Description
Powermedic ApS
2116
In Commercial Distribution

  • 05713592021166 ()


  • Musculoskeletal/physical therapy laser, home-use
No Description
Powermedic ApS
2093
In Commercial Distribution

  • 05713592020930 ()


  • Musculoskeletal/physical therapy laser, home-use
No Description
Powermedic ApS
2089
In Commercial Distribution

  • 05713592020893 ()


  • Musculoskeletal/physical therapy laser, home-use
No Description
Powermedic ApS
2065
In Commercial Distribution

  • 05713592020657 ()


  • Musculoskeletal/physical therapy laser, home-use
Infrared Light Therapy Lamp
Beijing Choice Electronic Technology Co., Ltd.
CILTL1A1
In Commercial Distribution

  • 00846841012617 ()


  • Blue/red/infrared phototherapy lamp
The first wearable, wireless LED light patches for athletes in all sports: on the training field, on the road, even at home. CareWear Light Patches start relieving pain and accelerating recovery in just 30 minutes.
ZMI ELECTRONICS LTD.
CWC-1
In Commercial Distribution

  • 44719872330491 ()
  • 04719872330479 ()
  • 14719872330483 ()
  • 04719872330585 ()
  • 04719872330578 ()


  • Musculoskeletal/physical therapy laser, home-use
No Description
APPLIED BIOPHOTONICS LIMITED
ABPT1003
In Commercial Distribution

  • 04719873240012 ()


  • Red-light phototherapy unit, professional
  • Musculoskeletal infrared phototherapy unit, non-wearable
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
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
No Description
BLUBLOX PTY LTD
Red Light Face Wand
In Commercial Distribution

  • 09361725000081 ()


  • Cosmetic red-light phototherapy system, home-use
No Description
BLUBLOX PTY LTD
Mini Red Light Therapy Device
In Commercial Distribution

  • 09361725000074 ()


  • Cosmetic red-light phototherapy system, home-use
No Description
BLUBLOX PTY LTD
Red Light Therapy Blanket
In Commercial Distribution

  • 09361725000067 ()


  • Cosmetic red-light phototherapy system, home-use
No Description
BLUBLOX PTY LTD
Red Light Neck and Chest Mask
In Commercial Distribution

  • 09361725000050 ()


  • Cosmetic red-light phototherapy system, home-use
No Description
BLUBLOX PTY LTD
Red Light Face Mask
In Commercial Distribution

  • 09361725000043 ()


  • Cosmetic red-light phototherapy system, home-use
No Description
BLUBLOX PTY LTD
Super Max Red Light Therapy Device
In Commercial Distribution

  • 09361725000036 ()


  • Cosmetic red-light phototherapy system, home-use
No Description
BLUBLOX PTY LTD
Max Red Light Therapy Device
In Commercial Distribution

  • 09361725000029 ()


  • Cosmetic red-light phototherapy system, home-use
No Description
BLUBLOX PTY LTD
Demi Red Light Therapy Device
In Commercial Distribution

  • 09361725000012 ()


  • Cosmetic red-light phototherapy system, home-use
No Description
BLUBLOX PTY LTD
Bullet Red Light Therapy Device
In Commercial Distribution

  • 09361725000005 ()


  • Cosmetic red-light phototherapy system, home-use
The MedX SLD Light diode Cluster, with an output power of 500mW, is used together with the Richmar console to treat a variety of medical conditions.It is a light therapy device that can effectively treat conditions like pain, swelling, bruising, inflammation, wound healing and several other conditions. The device utilizes super-luminous diode technology in both infrared and visible red diodes which produce photons of energy and trigger physiological changes in tissue. With the included velcro flexstrap, the SLD cluster can be strapped to the body and be used hands-free or it can be hand-held over the area to be treated. This particular model is private-labeled for Richmar, a medical device company based in Chattanooga, TN, USA which makes medical devices used in physical therapy.
MedX Health Corp
MCT 507
In Commercial Distribution

  • 00628451918417 ()
  • 00628451918400 ()
  • 60628451918419 ()
  • 20628451918411 ()


  • Musculoskeletal/physical therapy laser, professional
The MedX Rehab Portable Laser cluster-stand alone, LCS 450, delivers high-quality Low Level Laser Therapy (LLLT). The battery powered, hand-held device is utilized to treat a variety of conditions such as swelling, bruising, pain management, inflammation and many other conditions. The device utilizes three near infrared laser diodes and one visible blue LED that deliver LLLT therapy. The MedX Portable Laser has a power output of 450 mW, and a wavelength of 808 nm and has been designed for licensed or certified healthcare professionals. This particular model is private-labeled for Richmar, a medical device company based in Chattanooga, TN, USA which makes medical devices used in physical therapy.
MedX Health Corp
0455
In Commercial Distribution

  • 00628451918387 ()
  • 00628451918394 ()
  • 90628451918397 ()


  • Musculoskeletal/physical therapy laser, professional
The MedX Rehab Laser cluster, stand alone, LCS 450, is a battery powered laser medical device accessory and is part of MedX Health kit Item # 0915. The hand-held device is utilized to treat a variety of conditions such as swelling, bruising, pain management, inflammation and many other conditions. The device utilizes three near infrared laser diodes and one visible blue LED that deliver LLLT therapy. ) This registration is to show the UDI for direct marking and primary packaging when this product shipped as a particular item, e.g. replacement or repaired unit, and not as a kit.
MedX Health Corp
LCS450
In Commercial Distribution

  • 00628451918356 ()
  • 00628451918226 ()


  • Musculoskeletal/physical therapy laser, professional
The Oralase Portable Laser, LPS200, delivers high-quality laser & light therapy for Oralase applications.The laser can be used in a variety of procedures to reduce pain, swelling, bleeding, bruising and other conditions. This device is the main reference for identification and traceability for MedX Health kit Item# 0910 This product is registered to show its UDI for direct marking and primary packaging when shipped as a particular item and not as a kit.
MedX Health Corp
LPS200
In Commercial Distribution

  • 00628451918196 ()
  • 00628451918349 ()


  • Musculoskeletal/physical therapy laser, professional
The MedX SLD Light diode Cluster is used together with the MedX Home console to treat a variety of medical conditions.It is a light therapy device that can effectively treat conditions like pain, swelling, bruising, inflammation, wound healing and several other conditions. The device utilizes super-luminous diode technology in both infrared and visible red diodes which produce photons of energy and trigger physiological changes in tissue. With the included velcro flexstrap, the SLD cluster can be strapped to the body and be used hands-free or it can be hand-held over the area to be treated.
MedX Health Corp
MCT1000
In Commercial Distribution

  • 00628451918332 ()
  • 00628451918172 ()


  • Musculoskeletal/physical therapy laser, professional
The MedX Home console or MBM 2030 controls and provides power to MedX SLD cluster MCT 1000. It is the main reference for identification and traceability, and part of the kit for MedX item number #2130. This registration shows its UDI for direct marking and primary packaging when shipped as a particular item and not as part of a kit.
MedX Health Corp
2030
In Commercial Distribution

  • 00628451918165 ()
  • 00628451918325 ()


  • Musculoskeletal/physical therapy laser, professional
The MedX Health portable-tethered laser medical device or LPT201 is part of the kit for MedX Health item numbers #3120 and #3122. It is controlled and powered by MedX Rehab Console MBM1100N. This product is registered for the purpose showing its UDI for direct marking and primary packaging when shipped as a particular item and not as part of a kit.
MedX Health Corp
201
In Commercial Distribution

  • 00628451918240 ()
  • 00628451918318 ()


  • Musculoskeletal/physical therapy laser, professional
The MedX Rehab Laser cluster-tethered, LCT450, laser medical device accessory is a hand-held Low Level Laser and light Therapy (LLLT) device for use to treat a wide variety of medical conditions. It is also used for treating deeper tissue conditions. This accessory contains three SLD near-infrared laser light diodes for therapeutic applications and a visible LED guide light. It is part of the kit for MedX Health Items #3114, #3116. LCT 450 is controlled and powered by MedX Rehab console 1100N. This registration shows its UDI for direct marking and primary packaging when shipped as a particular item and not as part of a kit.
MedX Health Corp
450
In Commercial Distribution

  • 00628451918301 ()
  • 00628451918134 ()


  • Musculoskeletal/physical therapy laser, professional
The MedX SLD Light Cluster accessory, MCT 1001, offers SLD light therapy for broader applications. This accessory can be strapped to the body for “hands-free”, unattended treatment. The accessory contains a large number of Light emitting diodes that are used to treat a variety of medical conditions such as swelling, inflammation, pain, bruising, wound healing and many other medical conditions. This laser medical device accessory is controlled and powered by MBM 1100N. This product is registered for the purpose of having a UDI for direct marking and primary packaging when shipped as a particular item and not as a kit.
MedX Health Corp
1001
In Commercial Distribution

  • 00628451918295 ()
  • 00628451918110 ()
  • 20628451918299 ()


  • Musculoskeletal/physical therapy laser, professional
The MedX Rehab Console 1100N controls and powers the MedX tethered laser medical device accessories like the Multi-cluster, tethered MCT1001, Laser cluster, tethered LCT450 and Laser probe, tethered LPT 201. It is the main reference for identification and traceability, and part of the kit for MedX Health Item numbers #3110, #3114, #3116, #3120, and #3122. This product is registered for the purpose of having a UDI for direct marking and primary packaging when shipped as a particular item and not as a kit.
MedX Health Corp
1100N
In Commercial Distribution

  • 00628451918288 ()
  • 00628451918103 ()


  • Musculoskeletal/physical therapy laser, professional
The MedX Oralase Console system is a therapeutic Low-Level Laser and Light therapy system for Oralase application. It features a handheld laser device, tethered to a console, which provides low level laser therapy to a smaller focused treatment area. The single near-infra-red laser diode tip has a visible LED guide light for pinpoint application. The MedX 1100N console powers the handheld laser therapy device.
MedX Health Corp
3122
In Commercial Distribution

  • 00628451918103 ()
  • 00628451918264 ()
  • 50628451918269 ()
  • 30628451918265 ()
  • 20628451918268 ()


  • Musculoskeletal/physical therapy laser, professional
The MedX Oralase Console system is a therapeutic Low-Level Laser and Light therapy system for Oralase application. It features a handheld laser device which provides low level laser therapy to a smaller focused treatment area. The single near-infra-red laser diode tip has a visible LED guide light and can be used with either the intra-oral or extra-oral light guides. The MedX 1100N console powers the handheld laser therapy device and also two SLD accessories. The MedX SLD Light cluster accessory offers light therapy for broader treatment applications. This accessory can be strapped to the body for “hands-free” unattended treatment.
MedX Health Corp
3120
In Commercial Distribution

  • 00628451918103 ()
  • 00628451918257 ()
  • 50628451918252 ()
  • 30628451918258 ()
  • 20628451918251 ()


  • Musculoskeletal/physical therapy laser, professional
The MedX Rehab Portable Laser cluster-stand alone, LCS 450, delivers high-quality Low Level Laser Therapy (LLLT). The battery powered, hand-held device is utilized to treat a variety of conditions such as swelling, bruising, pain management, inflammation and many other conditions. The device utilizes three near infrared laser diodes and one visible blue LED that deliver LLLT therapy. The MedX Portable Laser has a power output of 450 mW, and a wavelength of 808 nm and has been designed for licensed or certified healthcare professionals.
MedX Health Corp
0915
In Commercial Distribution

  • 00628451918226 ()
  • 00628451918233 ()
  • 70628451918232 ()
  • 40628451918231 ()
  • 50628451918238 ()
  • 30628451918234 ()
  • 20628451918237 ()

  • Weight: 113 Gram


  • Musculoskeletal/physical therapy laser, professional
The Acupuncture Portable Laser delivers high-quality auricular laser acupuncture therapy. The device features one GaAIAs near-infrared laser diode and three visible red LEDs and a special fiber optic light guide tip that deliver low level laser & light therapy to very small trigger points on the ear. The Acupuncture Portable Laser has been designed for licensed or certified healthcare professionals.
MedX Health Corp
0912
In Commercial Distribution

  • 00628451918196 ()
  • 00628451918219 ()
  • 50628451918214 ()
  • 30628451918210 ()
  • 20628451918213 ()

  • Weight: 190 Gram


  • Musculoskeletal/physical therapy laser, professional
The Oralase Portable Portable Laser delivers high-quality laser & light therapy for Oralase applications.The laser can be used in a variety of procedures to reduce pain, swelling, bleeding, bruising and other conditions. The device features one GaAIAs near-infrared laser diode and three visible red guide LEDs that deliver laser & light therapy. The Oralase Portable Laser has been designed for licensed or certified healthcare professionals.
MedX Health Corp
0910
In Commercial Distribution

  • 00628451918196 ()
  • 00628451918202 ()
  • 60628451918204 ()
  • 40628451918200 ()
  • 50628451918207 ()
  • 30628451918203 ()
  • 20628451918206 ()


  • Musculoskeletal/physical therapy laser, professional
The MedX Brand Light Therapy home unit is a light therapy system for home use. It is used by the patient to treat a variety of medical conditions such a chronic pain, swelling, inflammation, bruising, wound healing, and much more. The device utilizes an LED light diode cluster that contain a large number of red light diodes. The cluster can be attached to the skin surface with the velcro straps prior to beginning a treatment.
MedX Health Corp
2031
In Commercial Distribution

  • 00628451918189 ()
  • 00628451918165 ()
  • 50628451918184 ()
  • 30628451918180 ()
  • 20628451918183 ()


  • Musculoskeletal/physical therapy laser, professional
The MedX Rehab Console System is a therapeutic Low-Level Laser therapy system used for the treatment of a variety of medical conditions such as pain management, swelling, inflammation, bruising, wound healing and many other conditions that require therapy. The device has been designed for ease of use by licensed healthcare professionals and/or designated assistants. The MedX MBM1100N Console powers the high quality handheld laser therapy device and also two SLD light diode cluster accessories. The MedX SLD Light Cluster accessory offers SLD light therapy for broader treatment applications. This accessory can be strapped to the body for "hands-free" unattended treatment.
MedX Health Corp
3116
In Commercial Distribution

  • 00628451918103 ()
  • 00628451918158 ()
  • 30628451918159 ()
  • 50628451918153 ()
  • 20628451918152 ()
  • 40628451918156 ()


  • Musculoskeletal/physical therapy laser, professional
The MedX Rehab Console System is a Low-Level Laser therapy system used for the treatment of a variety of medical conditions such as pain management, swelling, inflammation, bruising, wound healing and many other conditions that require therapy. . The device has been designed for ease of use by licensed healthcare professionals and/or designated assistants. The MedX MBM 1100N console powers the one (1) laser therapy device.
MedX Health Corp
3114
In Commercial Distribution

  • 00628451918103 ()
  • 00628451918141 ()
  • 50628451918146 ()
  • 30628451918142 ()
  • 20628451918145 ()


  • Musculoskeletal/physical therapy laser, professional
The MedX Rehab Laser Console System is a Low-Level Laser therapy system used for the treatment of a variety of medical conditions such as pain management, swelling, inflammation, bruise and many other conditions that require therapy. The device has been designed for ease of use by licensed healthcare professionals and/or designated assistants. The MedX MBM1100N Console powers three SLD light diode cluster accessories. The MedX SLD Light Cluster accessory offers SLD light therapy for broader variety of applications. This Cluster accessories can be strapped to the body for "hands-free" unattended treatment.
MedX Health Corp
3110
In Commercial Distribution

  • 00628451918103 ()
  • 00628451918127 ()
  • 50628451918122 ()
  • 30628451918128 ()
  • 20628451918121 ()
  • 10628451918124 ()


  • Musculoskeletal/physical therapy laser, professional
Infrared Lamp
BEURER NORTH AMERICA, L.P.
IL51
In Commercial Distribution

  • 10850003500048 ()
  • 00850003500041 ()
Art.- No. 619.73

  • Musculoskeletal infrared phototherapy unit, non-wearable
Over the counter Red/IR LED Heating device for minor aches and pains, temporary increase in circulation.
Omm Imports Inc.
RX100
In Commercial Distribution

  • 00850001456357 ()


  • Musculoskeletal infrared phototherapy unit, non-wearable
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