K182333 is an FDA 510(k) clearance for the Vera. This device is classified as a Interactive Rehabilitation Exercise Devices (Class II - Special Controls, product code LXJ).
Submitted by Reflexion Health, Inc. (San Diego, US). The FDA issued a Cleared decision on April 9, 2019, 224 days after receiving the submission on August 28, 2018.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5360.
| 510(k) Number | K182333 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 28, 2018 |
| Decision Date | April 09, 2019 |
| Days to Decision | 224 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | Statement |
| Product Code | LXJ — Interactive Rehabilitation Exercise Devices |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 890.5360 |