K202031 is an FDA 510(k) clearance for the Talent-Pro Electromagnetic Stimulator. This device is classified as a Stimulator, Muscle, Powered (Class II - Special Controls, product code IPF).
Submitted by Remed Co., Ltd. (Daejeon, KR). The FDA issued a Cleared decision on May 6, 2021, 288 days after receiving the submission on July 22, 2020.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5850.
| 510(k) Number | K202031 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 22, 2020 |
| Decision Date | May 06, 2021 |
| Days to Decision | 288 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | Summary PDF |
| Product Code | IPF - Stimulator, Muscle, Powered |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 890.5850 |