K172384 is an FDA 510(k) clearance for the Quickie(r) Q700-UP M. This device is classified as a Wheelchair, Standup (Class II - Special Controls, product code IPL).
Submitted by Sunrise Medical (Us), LLC (Fresno, US). The FDA issued a Cleared decision on January 16, 2018, 161 days after receiving the submission on August 8, 2017.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.3900.
| 510(k) Number | K172384 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 08, 2017 |
| Decision Date | January 16, 2018 |
| Days to Decision | 161 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 |