K192733 is an FDA 510(k) clearance for the RelieforMe TENS/EMS Device Model UPK-GE01. This device is classified as a Stimulator, Muscle, Powered (Class II - Special Controls, product code IPF).
Submitted by Umeheal , Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on December 23, 2019, 87 days after receiving the submission on September 27, 2019.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5850.
| 510(k) Number | K192733 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 27, 2019 |
| Decision Date | December 23, 2019 |
| Days to Decision | 87 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 |