K191376 is an FDA 510(k) clearance for the Modular Power Standing System. This device is classified as a Wheelchair, Standup (Class II - Special Controls, product code IPL).
Submitted by Motion Concepts (Concord, CA). The FDA issued a Cleared decision on August 13, 2019, 82 days after receiving the submission on May 23, 2019.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.3900.
| 510(k) Number | K191376 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 23, 2019 |
| Decision Date | August 13, 2019 |
| Days to Decision | 82 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 |