K211919 is an FDA 510(k) clearance for the KISS Dynamic Back Support, KISS Dynamic Solid Drop Seat. This device is classified as a Components, Wheelchair (Class I - General Controls, product code KNN).
Submitted by Kinetic Innovative Seating System, LLC (Branford, US). The FDA issued a Cleared decision on March 4, 2022, 256 days after receiving the submission on June 21, 2021.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.3920.
| 510(k) Number | K211919 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 21, 2021 |
| Decision Date | March 04, 2022 |
| Days to Decision | 256 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | Summary PDF |
| Product Code | KNN — Components, Wheelchair |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 890.3920 |