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MYOTRAC2D/Cs

by Thought Technology Ltd.

510(k) K925681

MYOTRAC2D/Cs is a Class II device made by Thought Technology Ltd., cleared under FDA 510(k) K925681 on 29 Sep 1995, 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 NumberK925681 Date29 Sep 1995ClearedStatusActive

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  • Withdrawn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
HIR
FDA applicant
Thought Technology , Ltd.
Device class
Class II
Regulation
21 CFR Part 884.1425
Advisory committee
Obstetrics/Gynecology
FDA decision
SESE Substantially Equivalent

Devices cleared under K925681

1 device · 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 K925681
UDI-DISize and differences
Myotrac 3 Unit SA9900
Thought Technology Ltd.
SA990007540191000494 —On the market

Similar devices

Other devices filed under FDA product code HIR (Perineometer).

Other devices from Thought Technology Ltd.

See all devices from Thought Technology Ltd. →