Stimulator, Muscle, Powered, For Muscle Conditioning
NGX · Class II — Moderate Risk (510(k) clearance required) · Physical Medicine · 21 CFR 890.5850
Classification
FDA Product Code
NGX
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
A powered muscle stimulator for muscle conditioning is a device used for other than medical purposes to apply an electrical current to electrodes on a person's skin to temporarily affect the stimulated muscle's contractile properties, force output, and/or fatigue resistance. Unlike the classified Powered Muscle Stimulator devices intended for use in physical medicine and rehabilitation, this device is not intended for use in patients with medical conditions and is intended only for muscle conditioning purposes.