Summer Body Red Light Belt with EMS - Electrical Muscle Stimulation
The new Summer Body Red Light Belt is perfect for the belly with optional EMS Muscle Stimulation. 22.44 x 5 inches
Easy to use with ability to run just 660 nm, 850 nm or both together. Set the time for 30 minutes and run. EMS set to desired intesity
Rating Power 84W Actual Power 25W LED QTY 140*0.6W Net Weight0.3KG Wavelength 660nm + 850nm EMF 0 Irradiance 0 Inch:>180mW/c㎡ Timer 30 Minutes Material Fabric Lifespan Lifespan Over 50,000Hours
1 Pad 1 Power Adapter 1 Control Line 1 Connecting Wire 1 User Manual Not for children or pregnant women
Do not exeed 60 Minutes per session
Build to ISO 60601 requirements ISO 13485 compliant ISO International Medical manufacturing supplier 890.55 Regulation Number zero EMF
SAFETYRed 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.
890.5350 Exercise Component. For the Intended Use to: Restoration of motion to joints, redevelop muscles and as an adjunct to obesity as part of a diet and exercise program.
§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).
§890.5380 Powered exercise equipment.
(a) Identification. Powered exercise equipment consist of powered devices intended for medical purposes, such as to redevelop muscles or restore motion to joints or for use as an adjunct treatment for obesity. (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.
Summer Body Red Light Belt
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