K190682 is an FDA 510(k) clearance for the Explorer Mini. 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 February 27, 2020, 346 days after receiving the submission on March 18, 2019.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.3900.
| 510(k) Number | K190682 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 18, 2019 |
| Decision Date | February 27, 2020 |
| Days to Decision | 346 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 |