BX-400
Device Facts
| Record ID | K842142 |
|---|---|
| Device Name | BX-400 |
| Applicant | Bloomex International, Inc. |
| Product Code | IPF · Physical Medicine |
| Decision Date | Jun 25, 1984 |
| 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.
