SLENDERTONE FLEX, MODEL, 512
Device Facts
| Record ID | K010335 |
|---|---|
| Device Name | SLENDERTONE FLEX, MODEL, 512 |
| Applicant | Bio-Medical Research, Ltd. |
| Product Code | NGX · Physical Medicine |
| Decision Date | Sep 27, 2001 |
| 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.
