K091043 is an FDA 510(k) clearance for the POWER DRIVE CHAIR, MODEL: TMM6. This device is classified as a Stretcher, Wheeled, Powered (Class II - Special Controls, product code INK).
Submitted by Transmotion Medical, Inc. (Cleveland, US). The FDA issued a Cleared decision on May 11, 2009, 28 days after receiving the submission on April 13, 2009.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.3690.
| 510(k) Number | K091043 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 13, 2009 |
| Decision Date | May 11, 2009 |
| Days to Decision | 28 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | Summary PDF |
| Product Code | INK — Stretcher, Wheeled, Powered |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 890.3690 |