Stimulator, Muscle, Powered, With Limited Output, For Muscle Conditioning
NYZ · Class II — Moderate Risk (510(k) clearance required) · Physical Medicine · 21 CFR 890.5850
Classification
FDA Product Code
NYZ
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 890.5850
Review panel
PM
Medical specialty
Physical Medicine
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
Y
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.