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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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LS Pro Systems Target Pad 90 red/infrared LED flexi-pad. 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. Must be used with LS power controller.
WELLNESS WITHOUT LIMITS LLC
T90
In Commercial Distribution

  • 00850061407092 ()


  • Red/infrared light phototherapy unit
LS Pro Systems Face Pad 104 blue/red/ LED flexi-pad. Intended to emit both red and blue light for the treatment of a facial skin conditions and help with mood, circadian rhythm, sleep, and relaxation. It may also have an anti-inflammatory effect on keratinocytes, the most common cells in the outer layer of the skin. Promotes circulation at the skin level and can increase elasticity/collagen. Must be used with LS power controller.
WELLNESS WITHOUT LIMITS LLC
F104
In Commercial Distribution

  • 00850061407085 ()


  • Red/blue light phototherapy unit
LS Pro Systems Local Pad Blue 132 blue/infrared LED flexi-pad. Intended to deliver light in blue and infrared spectrums to the skin to help kill off acne-causing bacteria and reduces activity in oil-secreting glands; It may also have an anti-inflammatory effect on keratinocytes, the most common cells in the outer layer of the skin and can benefit skin elasticity. Must be used with LS power controller.
WELLNESS WITHOUT LIMITS LLC
L132B
In Commercial Distribution

  • 00850061407078 ()


  • Blue-light phototherapy lamp, home-use
LS Pro Systems Local Pad 132 red/infrared LED flexi-pad. 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. Must be used with LS power controller.
WELLNESS WITHOUT LIMITS LLC
L132
In Commercial Distribution

  • 00850061407061 ()


  • Red/infrared light phototherapy unit
LS Pro Systems General Red 264 red/infrared LED flexi-pad. 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. Must be used with LS power controller.
WELLNESS WITHOUT LIMITS LLC
G264
In Commercial Distribution

  • 00850061407030 ()


  • Red/infrared light phototherapy unit
LS Pro Systems 6 Port Controller power supply for LS Pro Systems LED therapeutic pad
WELLNESS WITHOUT LIMITS LLC
XP6
In Commercial Distribution

  • 00850061407023 ()


  • Red/infrared light phototherapy unit
LS Pro Systems 3 Port Controller power supply for LS Pro Systems LED therapeutic pad
WELLNESS WITHOUT LIMITS LLC
XP3
In Commercial Distribution

  • 00850061407016 ()


  • Red/infrared light phototherapy unit
LS Pro Systems 1 Port Controller power supply for LS Pro Systems LED therapeutic pad
WELLNESS WITHOUT LIMITS LLC
XP1
In Commercial Distribution

  • 00850061407009 ()


  • Red/infrared light phototherapy unit
Apollo laser handheld
PIVOTAL HEALTH SOLUTIONS, INC.
Handheld, HH
In Commercial Distribution

  • 00852753008969 ()


  • Musculoskeletal/physical therapy laser, home-use
Apollo portable laser system
PIVOTAL HEALTH SOLUTIONS, INC.
Portable, AP2-PT
In Commercial Distribution

  • 00852753008891 ()


  • Musculoskeletal/physical therapy laser, home-use
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