• 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

 Light Therapy is an adjunct to obesity when combined with diet and exercise.  These are General Wellness Products and have a low risk to users safety.  No Physician or license is required to light therapy services to others.   

This type of therapy offers a safe, non-invasive alternative for helping people improve their looks and their overall health. 

SAFETY & CLEARANCE

*Red Light 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. 510k clearance is not required.

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.

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