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Forcetrac SA7600

by Thought Technology Ltd.

Forcetrac SA7600 is a Class II device made by Thought Technology Ltd., cleared under FDA 510(k) K903497 on 12 Feb 1991 and listed in FDA GUDID since 31 Aug 2017 (UDI-DI 07540191000098), active as of 23 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 23 Oct 2026

Documents

510(k) K903497

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number07540191000098 UDI-DI Date31 Aug 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK903497 Date12 Feb 1991DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K903497 decided 12 Feb 1991 Active
  • FDA GUDID UDI-DI 07540191000098 listed 31 Aug 2017 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K903497
  2. Listed FDA GUDID 07540191000098

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Forcetrac
Generic name
Psychophysiological biofeedback system
Model / reference
SA7600
Primary DI / UDI-DI
07540191000098
510(k) Number
FDA product code
HCC
GMDN term
Psychophysiological biofeedback system
Device class
Class II
Regulation number
882.5050
GUDID distribution status
In Commercial Distribution

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Properties

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