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MyOnyx System

by Thought Technology Ltd.

510(k) K213197Ref SA9020

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 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K213197↗

+1 more

Trust

Unverified

Source EUDAMED, FDA 510(k), GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-07540191000593 Basic UDI-DI 07540191000593UDI-DIDate20 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07540191000593 UDI-DI Date7 Jun 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK213197 Date17 Jun 2022ClearedStatusActive
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK201014 Date13 Jan 2021DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-07540191000593 registered 20 May 2026 Active
  • FDA 510(k) K213197 decided 17 Jun 2022 Active· +1 more in the status table
  • FDA GUDID UDI-DI 07540191000593 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 07540191000593
  4. Registered EUDAMED B-07540191000593

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  • Withdrawn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 · 510(k) · GUDID

Trade name
MyOnyx
Generic name
Psychophysiological biofeedback system
Model / reference
SA9020
FDA applicant
Thought Technology , Ltd.
Primary DI / UDI-DI
07540191000593
Basic UDI-DI
B-07540191000593
510(k) Number
FDA product code
IPF, KPI, HCC, GZJ
EMDN code
N01028099, U070399, Z12062401, Z12062899
GMDN term
Psychophysiological biofeedback system
Device class
Class IIa EUDAMED
Class II 510(k)GUDID
Regulation
21 CFR Part 890.5850 510(k)GUDID
876.5320 GUDID
882.5050 GUDID
882.5890 GUDID
EU registration type
Legacy device (under a directive)
EU market of registration
France
Advisory committee
Physical Medicine
FDA decision
SESE Substantially Equivalent
GUDID distribution status
In Commercial Distribution

Truth per registry

3 sources · 1 field differs

FieldEUDAMED510(k)GUDID
Device classEUDAMED
Class IIa
510(k)
Class II
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 510(k), FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Source: 510k-lineage (choiben314), CC BY 4.0

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The MyOnyx System is a powered muscle stimulation device classified as an electrical stimulator, non-implantable. It is designed to address muscle spasms, facilitate muscle re-education, prevent or slow disuse atrophy, improve range of motion, enhance local blood circulation, and reduce post-surgical venous thrombosis risk through targeted calf muscle stimulation.

The device is supplied as a reusable system and is intended for clinical use in physical medicine settings. It operates under FDA 510(k) clearance (K213197) and complies with the Medical Device Directive (MDD). No specific sterility or MRI safety information is provided in the available data, and no single-use designation is indicated.

Devices cleared under K213197

2 devices · 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 K213197
UDI-DISize and differences
MyOnyx Mobile App SA9030
Thought Technology Ltd.
SA903007540191000586 —On the market
MyOnyx SA9020
Thought Technology Ltd.
SA902007540191000593 —On the market

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Properties

  • Serial number
  • Manufacturing date
Other properties (21, all answered No)