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TAMA BEMS device

by Tama Research Corporation

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 United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK173093 Date5 Jun 2018ClearedStatusActive

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

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

6 devices · FDA GUDID

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.

Devices cleared under K173093
UDI-DISize and differences
BlackOnyx TA1021
Tama Research Corporation
TA1021 / TA102100860001881561 —On the market
BlueOnyx Pro TA1012
Tama Research Corporation
TA1012 / TA101200860001881523 —On the market
BlueOnyx Quad TA1014
Tama Research Corporation
TA1014 / TA101400860001881509 —On the market
MiTAMA Clear TA1018
Tama Research Corporation
TA1018 / TA101800860001881554 —On the market
MiTAMA Deluxe TA1017
Tama Research Corporation
TA1017 / TA101700860001881516 —On the market
MiTAMA Renew Plus TA1015+
Tama Research Corporation
TA1015+ / TA1015+00860001881547 —On the market

Similar devices

Other devices filed under FDA product code NFO (Stimulator, Transcutaneous Electrical, Aesthetic Purposes).

Other devices from Tama Research Corporation

See all devices from Tama Research Corporation →