NYZ — Stimulator, Muscle, Powered, With Limited Output, For Muscle Conditioning Class II
FDA product code NYZ covers "Stimulator, Muscle, Powered, With Limited Output, For Muscle Conditioning", a Class II medical device regulated under 21 CFR 890.5850. Submissions are reviewed by the Physical Medicine panel.
Classification Details
- Product Code
- NYZ
- Device Class
- Class II
- Regulation Number
- 890.5850
- Submission Type
- Review Panel
- PM
- Medical Specialty
- Physical Medicine
- Implant
- No
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.