COMMUTER (MANUAL/POWER WHEELCLHAIR)
Device Facts
| Record ID | K934232 |
|---|---|
| Device Name | COMMUTER (MANUAL/POWER WHEELCLHAIR) |
| Applicant | Fortress Lite-Style Wheelchairs, Inc. |
| Product Code | ITI · Physical Medicine |
| Decision Date | Mar 29, 1994 |
| Decision | SN |
| Submission Type | Traditional |
| Regulation | 21 CFR 890.3860 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A powered wheelchair is a battery-operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.