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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BIO300NIR
PLATINUM LED HOLDINGS LLC
BIO300NIR
In Commercial Distribution

  • B842BIO300NIR0 ()

  • 300w
  • 19"x9"x3"
  • Weight: 11 Pound
BIO300NIR

  • Blue/red/infrared phototherapy lamp
No Description
Wuhan PHOMED Technology Co., Ltd.
250WLS
In Commercial Distribution

  • G180DIOWAVE250WLS0 ()


  • Musculoskeletal infrared phototherapy unit, non-wearable
No Description
Wuhan PHOMED Technology Co., Ltd.
100WLS
In Commercial Distribution

  • G180DIOWAVE100WLS0 ()


  • Musculoskeletal infrared phototherapy unit, non-wearable
red/infrared light phototherapy unit
Ochs Labs LLC
1
In Commercial Distribution

  • G253R30 ()


  • Red/infrared light phototherapy unit
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 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
5i Series Infrared (975nm) and Red (638nm) Laser Module
528 Innovations LLC
5i Series 975nm Laser Module
In Commercial Distribution

  • G6815L21000 ()
5L2100

  • Musculoskeletal/physical therapy laser, home-use
5i Series Infrared (808nm) and Red (638nm) Laser Module
528 Innovations LLC
5i Series 808nm Laser Module
In Commercial Distribution

  • G6815L11000 ()
5L1100

  • Musculoskeletal/physical therapy laser, home-use
5i Series Laser Therapy Handset (device) with bluetooth connectivity and user interface
528 Innovations LLC
5i Series Laser Therapy Handset
In Commercial Distribution

  • G6815H11000 ()
5H1100

  • Musculoskeletal/physical therapy laser, home-use
5i Series Rechargeable battery
528 Innovations LLC
5i Series Rechargeable Battery
In Commercial Distribution

  • G6815B11000 ()
5B1100

  • Musculoskeletal/physical therapy laser, home-use
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