K163451 is an FDA 510(k) clearance for the Action Trackstander models TR1816, TR1820, TR2016, and TR2020. 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 January 12, 2018, 400 days after receiving the submission on December 8, 2016.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.3900.
| 510(k) Number | K163451 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 08, 2016 |
| Decision Date | January 12, 2018 |
| Days to Decision | 400 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 |