TAMA BEMS device
510(k) K173093
TAMA BEMS device is a medical device (FDA Class II; FDA product code NFO, Stimulator, Transcutaneous Electrical, Aesthetic Purposes) made by Tama Research Corporation, cleared under FDA 510(k) K173093 on 5 Jun 2018, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK173093 | Date5 Jun 2018 | StatusActive |
Official records
- FDA 510(k) database K173093
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- NFO
- Device class
- Class II
- Regulation
- 21 CFR Part 882.5890
- Advisory committee
- Neurology
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K173093
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| BlackOnyx TA1021 | TA1021 / TA1021 | 00860001881561 | — | On the market |
| BlueOnyx Pro TA1012 | TA1012 / TA1012 | 00860001881523 | — | On the market |
| BlueOnyx Quad TA1014 | TA1014 / TA1014 | 00860001881509 | — | On the market |
| MiTAMA Clear TA1018 | TA1018 / TA1018 | 00860001881554 | — | On the market |
| MiTAMA Deluxe TA1017 | TA1017 / TA1017 | 00860001881516 | — | On the market |
| MiTAMA Renew Plus TA1015+ | TA1015+ / TA1015+ | 00860001881547 | — | On the market |
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