K150462 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 October 30, 2015, 249 days after receiving the submission on February 23, 2015.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5360.
| 510(k) Number | K150462 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 23, 2015 |
| Decision Date | October 30, 2015 |
| Days to Decision | 249 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | Summary PDF |
| Product Code | LXJ — Interactive Rehabilitation Exercise Devices |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 890.5360 |