FDA WARNING_LETTER - SonicLife.com, LLC - July 02, 2015

During an FDA inspection from June 1 to July 2, 2015, of a firm in Hood River, Oregon, it was determined that the firm is the initial importer and distributor of whole body vibration devices: Professional VC-12, Pulsation VM-10, and Personal VH-11. These products are classified as devices under section 201(h) of the Federal Food, Drug, and Cosmetic Act.

The firm is marketing these devices without required clearance or approval, violating the Act. While powered exercise equipment for medical purposes are typically Class I devices exempt from premarket notification (21 CFR Part 890.5380), this exemption does not apply if the device is intended for a use different from a legally marketed device of that generic type (21 CFR 890.9). The inspection revealed the firm markets these devices with therapeutic and structure/function claims exceeding the limited medical purposes of typical powered exercise equipment (e.g., muscle redevelopment, joint motion restoration, adjunct obesity treatment).

Examples of promotional claims include improving muscular endurance by stimulating HGH, lymphatic drainage, injury rehabilitation, collagen production, hormone secretion (HGH, IGF-1, Testosterone, Serotonin, Norepinephrine), bone density, blood/oxygen/lymph circulation, prevention of metabolic/musculoskeletal/degenerative disorders, rehabilitation for knee osteoarthritis, lowering Cortisol, and creating a highly oxygenated environment to combat anaerobic pathogens.