The following data is part of a premarket notification filed by Mumease with the FDA for Tumease Acupressure Bracelets.
| Device ID | K193374 |
| 510k Number | K193374 |
| Device Name: | TumEase Acupressure Bracelets |
| Classification | Device, Acupressure |
| Applicant | MumEase 227 W 4th Street Charlotte, NC 28202 |
| Contact | Catherine Varley |
| Correspondent | Bill Jacqmein Medavice, Inc. 1321 Upland Drive; Suite 6792 Houston, TX 77043 |
| Product Code | MVV |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-12-05 |
| Decision Date | 2020-03-04 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860000032803 | K193374 | 000 |
| 00860002270258 | K193374 | 000 |
| 00860002270241 | K193374 | 000 |
| 00860002270234 | K193374 | 000 |
| 00860002270227 | K193374 | 000 |
| 00860002270210 | K193374 | 000 |
| 00860002270203 | K193374 | 000 |