21 CFR 890.5850 — Stimulator, Muscle, Powered

Physical Medicine (PM) · Part 890 Subpart F—Physical Medicine Therapeutic Devices · § 890.5850

Identification

A powered muscle stimulator is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area.

Classification Rationale

Class II (performance standards).

Product Codes

Product CodeDevice NameClassDevicesAttributes
IPFStimulator, Muscle, Powered25453rd Party
NGXStimulator, Muscle, Powered, For Muscle Conditioning21623rd Party
NUWStimulator, Muscle, Powered, Dental293rd Party
NYYStimulator, Muscle, Powered, With Limited Output, For Rehabilitation203rd Party
NYZStimulator, Muscle, Powered, With Limited Output, For Muscle Conditioning203rd Party
SGTElectromagnetic Stimulator For Healthy Muscle Stimulation213rd Party
Innolitics

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