K202728 is an FDA 510(k) clearance for the Action Trackchair Hawk. This device is classified as a Wheelchair, Standup (Class II - Special Controls, product code IPL).
Submitted by Action Manufacturing, Inc. (Marshall, US). The FDA issued a Cleared decision on February 10, 2022, 510 days after receiving the submission on September 18, 2020.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.3900.
| 510(k) Number | K202728 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 18, 2020 |
| Decision Date | February 10, 2022 |
| Days to Decision | 510 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | Statement |
| Product Code | IPL - Wheelchair, Standup |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 890.3900 |