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 Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| IPF | Stimulator, Muscle, Powered | 2 | 545 | 3rd Party |
| NGX | Stimulator, Muscle, Powered, For Muscle Conditioning | 2 | 162 | 3rd Party |
| NUW | Stimulator, Muscle, Powered, Dental | 2 | 9 | 3rd Party |
| NYY | Stimulator, Muscle, Powered, With Limited Output, For Rehabilitation | 2 | 0 | 3rd Party |
| NYZ | Stimulator, Muscle, Powered, With Limited Output, For Muscle Conditioning | 2 | 0 | 3rd Party |
| SGT | Electromagnetic Stimulator For Healthy Muscle Stimulation | 2 | 1 | 3rd Party |