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Sensor, Myoscan EMG SA9503M

by Thought Technology Ltd.

Part of a family of 16 devices: see the family page

Ref SA9503M

Sensor, Myoscan EMG SA9503M is a device classified as Class I in the EU and Class II in the US made by Thought Technology Ltd., registered in EUDAMED on 21 May 2026 (Basic UDI-DI 7540191000038V), cleared under FDA 510(k) K903497 on 12 Feb 1991 (1 earlier submission) and listed in FDA GUDID since 31 Aug 2017 (UDI-DI 07540191000227), active as of 24 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K903497

+1 more

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number7540191000038V Basic UDI-DI 07540191000227UDI-DIDate21 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07540191000227 UDI-DI Date31 Aug 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK903497 Date12 Feb 1991DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 7540191000038V registered 21 May 2026 Active
  • FDA 510(k) K903497 decided 12 Feb 1991 Active· +1 more in the status table
  • FDA GUDID UDI-DI 07540191000227 listed 31 Aug 2017 Listed

Timeline

4 dated events

  1. Cleared FDA 510(k) K881416
  2. Cleared FDA 510(k) K903497
  3. Listed FDA GUDID 07540191000227
  4. Registered EUDAMED 7540191000038V

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Myoscan EUDAMED
Sensor, Myoscan EMG GUDID
Generic name
Psychophysiological biofeedback system
Device name
ProComp family
Model / reference
SA9503M
Primary DI / UDI-DI
07540191000227
Basic UDI-DI
7540191000038V
510(k) Number
FDA product code
HCC
EMDN code
Z12062401 Electromyographic biofeedback systems
GMDN term
Psychophysiological biofeedback system
Device class
Class I EUDAMED
Class II GUDID
Regulation number
882.5050
EU registration type
Standard device
EU market of registration
France
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class I
GUDID
Class II

Device class is stated on each registry's own scale: Class I in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Psychophysiological biofeedback system

Cleared under the same submission (K881416)

Cleared under the same submission (K903497)

and 8 more cleared under K903497

Similar devices in this category

Other devices filed under ELECTROMYOGRAPHIC BIOFEEDBACK SYSTEMS.

Other devices from Thought Technology Ltd.

See all devices from Thought Technology Ltd. →

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (22, all answered No)