Sensor, EEG FLEX/PRO SA9305M

by Thought Technology Ltd.

Sensor, EEG FLEX/PRO SA9305M 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 07540191000135), 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

FDA submission, from GUDID

Trust

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number07540191000135 UDI-DI	Date31 Aug 2017Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK903497	Date12 Feb 1991Decided	StatusActive

Official records

AccessGUDID record UDI-DI 07540191000135
FDA 510(k) database 510(k) number K903497

Across registries

2 registries list this device

FDA 510(k) K903497 decided 12 Feb 1991 Active
FDA GUDID UDI-DI 07540191000135 listed 31 Aug 2017 Listed

Timeline

2 dated events

12 Feb 1991 Cleared FDA 510(k) K903497
31 Aug 2017 Listed FDA GUDID 07540191000135

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: Sensor, EEG FLEX/PRO
Generic name: Psychophysiological biofeedback system
Model / reference: SA9305M

Primary DI / UDI-DI: 07540191000135
510(k) Number: K903497
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)