K193374 is an FDA 510(k) clearance for the TumEase Acupressure Bracelets. This device is classified as a Device, Acupressure.
Submitted by Mumease (Charlotte, US). The FDA issued a Cleared decision on March 4, 2020, 90 days after receiving the submission on December 5, 2019.
This device falls under the Neurology FDA review panel.
| 510(k) Number | K193374 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 05, 2019 |
| Decision Date | March 04, 2020 |
| Days to Decision | 90 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | MVV - Device, Acupressure |
| Device Class | - |