K152056 is an FDA 510(k) clearance for the Winco Model S550 Stretchair. This device is classified as a Stretcher, Wheeled, Powered (Class II - Special Controls, product code INK).
Submitted by Winco Manufacturing, LLC (Ocala, US). The FDA issued a Cleared decision on April 11, 2016, 262 days after receiving the submission on July 24, 2015.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.3690.
| 510(k) Number | K152056 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 24, 2015 |
| Decision Date | April 11, 2016 |
| Days to Decision | 262 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | Summary PDF |
| Product Code | INK — Stretcher, Wheeled, Powered |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 890.3690 |