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MyOnyx Mobile App SA9030

by Thought Technology Ltd.

Ref SA9030

MyOnyx Mobile App SA9030 is a device classified as Class IIa in the EU and Class II in the US made by Thought Technology Ltd., registered in EUDAMED on 20 May 2026 (Basic UDI-DI B-07540191000586), cleared under FDA 510(k) K213197 on 17 Jun 2022 (1 earlier submission) and listed in FDA GUDID since 7 Jun 2023 (UDI-DI 07540191000586), active as of 23 Oct 2026.

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

CE MDD 510(k)

Valid until

No date given

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

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K213197

+1 more

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-07540191000586 Basic UDI-DI 07540191000586UDI-DIDate20 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07540191000586 UDI-DI Date7 Jun 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK213197 Date17 Jun 2022DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-07540191000586 registered 20 May 2026 Active
  • FDA 510(k) K213197 decided 17 Jun 2022 Active· +1 more in the status table
  • FDA GUDID UDI-DI 07540191000586 listed 7 Jun 2023 Listed

Timeline

4 dated events

  1. Cleared FDA 510(k) K201014
  2. Cleared FDA 510(k) K213197
  3. Listed FDA GUDID 07540191000586
  4. Registered EUDAMED B-07540191000586

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
MyOnyx Mobile App
Generic name
Psychophysiological biofeedback system
Model / reference
SA9030
Primary DI / UDI-DI
07540191000586
Basic UDI-DI
B-07540191000586
510(k) Number
FDA product code
KPI, HCC, IPF, GZJ
EMDN code
N01028099, U070399, Z12062492, Z12062892
GMDN term
Psychophysiological biofeedback system
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
876.5320, 882.5050, 890.5850, 882.5890
EU registration type
Legacy device (under a directive)
EU market of registration
France
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class II

Device class is stated on each registry's own scale: Class IIa 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: Physical therapy transcutaneous neuromuscular electrical stimulation systemPsychophysiological biofeedback systemPerineal orifice incontinence-control electrical stimulation system probe, reusable

Similar devices in this category

Other devices filed under NEUROLOGIC PHYSIOTHERAPHY DEVICES.

Other devices from Thought Technology Ltd.

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Properties

  • Lot / batch number
  • Manufacturing date
Other properties (21, all answered No)