NYZ

Stimulator, Muscle, Powered, With Limited Output, For Muscle Conditioning

Product code

NYZ

Device name

Stimulator, Muscle, Powered, With Limited Output, For Muscle Conditioning

Device class

Class 2

21 CFR

21 CFR 890.5850

Medical specialty

Physical Medicine

Marketing pathway

510(K)

Flag

Third-party review eligible

FDA classification definition

Used for muscle stimulation for muscle conditioning. Device repeatedly contracts muscles by passing pulsed electrical current through cutaneous electrodes and into the body. Temporarily affects the stimulated muscles contractile properties, force output, and/or fatigue resistance. Not intended to be used for medical purposes (e.g., rehabilitation), for aesthetic purposes (e.g., changing the physical appearance of the muscle or body), or for the purpose of improving athletic performance.

Definition text from the FDA device classification database (U.S. federal government work, public domain).