EMS300, EMS400, EMS8000
Device Facts
| Record ID | K912642 |
|---|---|
| Device Name | EMS300, EMS400, EMS8000 |
| Applicant | Skylark Device Co., Ltd. |
| Product Code | IPF · Physical Medicine |
| Decision Date | Dec 9, 1991 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 890.5850 |
| Device Class | Class 2 |
Regulatory Classification
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.
