K180880 is an FDA 510(k) clearance for the DARI Health. This device is classified as a Interactive Rehabilitation Exercise Devices (Class II - Special Controls, product code LXJ).
Submitted by Scientific Analytics, Inc. (Lincoln, US). The FDA issued a Cleared decision on March 7, 2019, 338 days after receiving the submission on April 3, 2018.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5360.
| 510(k) Number | K180880 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 03, 2018 |
| Decision Date | March 07, 2019 |
| Days to Decision | 338 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 |