K191874 is an FDA 510(k) clearance for the F5 Corpus VS. This device is classified as a Wheelchair, Standup (Class II - Special Controls, product code IPL).
Submitted by Permobil AB (Timra, SE). The FDA issued a Cleared decision on October 25, 2019, 105 days after receiving the submission on July 12, 2019.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.3900.
| 510(k) Number | K191874 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 12, 2019 |
| Decision Date | October 25, 2019 |
| Days to Decision | 105 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 |