K182257 is an FDA 510(k) clearance for the UPnRIDE. This device is classified as a Wheelchair, Standup (Class II - Special Controls, product code IPL).
Submitted by Upnride Robotics , Ltd. (Yokneam, IL). The FDA issued a Cleared decision on September 12, 2019, 387 days after receiving the submission on August 21, 2018.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.3900.
| 510(k) Number | K182257 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 21, 2018 |
| Decision Date | September 12, 2019 |
| Days to Decision | 387 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 |