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Therm-X AT

by Zenith Technical Innovations, LLC.

Ref TX0002

Therm-X AT (TX0002) is an inflatable hot/cold therapy pack/electric pump (EU MDR Class IIa; FDA Class II) made by Zenith Technical Innovations, LLC., registered in EUDAMED on 25 Mar 2026 (Basic UDI-DI 08500010960002B2), cleared under FDA 510(k) K240125 on 21 Jun 2024 (1 earlier submission) and listed in FDA GUDID since 13 Feb 2026 (UDI-DI 00850001096386), active as of 23 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 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K240125

+1 more

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number08500010960002B2 Basic UDI-DI 00850001096386UDI-DIDate25 Mar 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00850001096386 UDI-DI Date13 Feb 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Special NumberK240125 Date21 Jun 2024DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 08500010960002B2 registered 25 Mar 2026 Active
  • FDA 510(k) K240125 decided 21 Jun 2024 Active· +1 more in the status table
  • FDA GUDID UDI-DI 00850001096386 listed 13 Feb 2026 Listed

Timeline

4 dated events

  1. Cleared FDA 510(k) K181149
  2. Cleared FDA 510(k) K240125
  3. Listed FDA GUDID 00850001096386
  4. Registered EUDAMED 08500010960002B2

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  • Withdrawn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
Therm-X
Generic name
Inflatable hot/cold therapy pack/electric pump
Model / Ref / Catalog
TX0002, Therm-X AT
Primary DI / UDI-DI
00850001096386
Basic UDI-DI
08500010960002B2
Direct marketing DI
00850001096386
510(k) Number
FDA product code
JOW, ILO, IRP
EMDN code
Z120616 Electromechanical systems for physical therapy
GMDN term
Inflatable hot/cold therapy pack/electric pump
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
870.5800, 890.5720, 890.5650
EU registration type
Standard device
EU market of registration
France
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
TX0002
GUDID
Therm-X AT
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.

Manufacturer details

EUDAMED SRN
US-MF-000047832
Authorised representative
MedEnvoy Global BV NL-AR-000024028

Similar devices in this category

Other devices filed under ELECTROMECHANICAL SYSTEMS FOR PHYSICAL THERAPY.

Other devices from Zenith Technical Innovations, LLC.

See all devices from Zenith Technical Innovations, LLC. →

Properties

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