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BlackOnyx TA1021

by Tama Research Corporation

BlackOnyx TA1021 is a multi-modality physical therapy system (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 and listed in FDA GUDID since 29 Nov 2023 (UDI-DI 00860001881561), active as of 22 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

510(k) K173093

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00860001881561 UDI-DI Date29 Nov 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK173093 Date5 Jun 2018DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K173093 decided 5 Jun 2018 Active
  • FDA GUDID UDI-DI 00860001881561 listed 29 Nov 2023 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K173093
  2. Listed FDA GUDID 00860001881561

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
BlackOnyx
Generic name
Multi-modality physical therapy system, non-simultaneous, professional-use
Model / Ref / Catalog
TA1021
Primary DI / UDI-DI
00860001881561
510(k) Number
FDA product code
NFO
GMDN term
Multi-modality physical therapy system, non-simultaneous, professional-use
Device class
Class II
Regulation number
882.5890
GUDID distribution status
In Commercial Distribution

Related devices

Category: Multi-modality physical therapy system, professional-use

Cleared under the same submission (K173093)

and 1 more cleared under K173093

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 →

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (12, all answered No)