K203761 is an FDA 510(k) clearance for the ParaMotion. This device is classified as a Wheelchair, Standup (Class II - Special Controls, product code IPL).
Submitted by Powerbasetec GmbH (Bodensee, DE). The FDA issued a Cleared decision on January 21, 2022, 394 days after receiving the submission on December 23, 2020.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.3900.
| 510(k) Number | K203761 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 23, 2020 |
| Decision Date | January 21, 2022 |
| Days to Decision | 394 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | Summary PDF |
| Product Code | IPL - Wheelchair, Standup |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 890.3900 |