K172882 is an FDA 510(k) clearance for the UINCARE HOME. This device is classified as a Interactive Rehabilitation Exercise Devices (Class II - Special Controls, product code LXJ).
Submitted by Uincare Corp. (Geumcheon-Gu, KR). The FDA issued a Cleared decision on May 10, 2018, 231 days after receiving the submission on September 21, 2017.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5360.
| 510(k) Number | K172882 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 21, 2017 |
| Decision Date | May 10, 2018 |
| Days to Decision | 231 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 |