Summer Body Red Light Pads
1 Summer Body RedPad with Tens
- SKU:
- summerbodyredlightpadminiwithtens
- Weight:
- 1.00 LBS
Description
Summer Body Red Light Belt
The new Summer Body Red Light Belt is perfect for the belly or back. 31 x 8 inches with 360 leds that are .5 w each 50W with 180W results
Easy to use with ability to run just 660nm, 850 nm or both together. Set the time for 20 minutes and run
3 Year Warranty
Build to ISO 60601 requirements
ISO 13485 compliant ISO International Medical manufacturing supplier
890.55 Regulation Number
zero EMF
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SAFETY
Red Light Therapy or Low Level Laser Therapy is considered a general wellness product under FDA 21 CFR and is intended only for general wellness use and presents a very low risk to users’ safety. This system encourages a general state of health or a healthy activity and is part of a exercise and diet program and promotes a healthy lifestyle. FDA 510K premarket notification is not required.
§890.5500 Infrared lamp. (a) Identification. An infrared lamp is a device intended for medical purposes that emits energy at infrared frequencies (approximately 700 nanometers to 50,000 nanometers) to provide topical heating. (b) Classification. Class II (performance standards).
(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in §890.9.
FDA Intended Use
• Restoration of Motion to Joints • Redevelop Muscles • Adjunct to Obesity as part of a diet and exercise program• Relaxation of muscles and relief from muscle spasms • Temporary relief of minor muscle and joint aches, pain and stiffness • Temporary relief of minor pain and stiffness associated with Arthritis • Temporarily increase blood circulation.