Compliance Consultants is familiar with the regulatory issues and has submitted 510(k)s for this relatively new device classification having non- medical claims: Powered Muscle Stimulator. In most cases, these devices have various conditioning, rehabilitative and cosmetic benefits. Many do not require a Class II 510(k) pre-market application. Requirements are based on claims that are limited based on clinical evidence.


Regulation Number: 21 CFR 890.5850, Product Code: NYY and NGX and NYZ.