INNOVA WHEELCHAIR
Device Facts
| Record ID | K110788 |
|---|---|
| Device Name | INNOVA WHEELCHAIR |
| Applicant | Columbia Medical Manufacturing, LLC |
| Product Code | IOR · Physical Medicine |
| Decision Date | May 6, 2011 |
| Decision | SESE |
| Submission Type | Abbreviated |
| Regulation | 21 CFR 890.3850 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A mechanical wheelchair is a manually operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.