Skip to content

Therm-X HOME

by Zenith Technical Innovations, LLC. 3 variants

Therm-X HOME (TX0300) is an inflatable hot/cold therapy pack/electric pump (FDA Class II) made by Zenith Technical Innovations, LLC., listed in FDA GUDID since 13 Feb 2026 (UDI-DI 00850001096508), registry data as of 23 Oct 2026.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00850001096508 UDI-DI Date13 Feb 2026ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade name
Therm-X
Generic name
Inflatable hot/cold therapy pack/electric pump
Model / Ref / Catalog
Therm-X HOME, TX0300
Primary DI / UDI-DI
00850001096508
FDA product code
JOW, ILO, IRP
GMDN term
Inflatable hot/cold therapy pack/electric pump
Device class
Class II
Regulation number
870.5800, 890.5720, 890.5650
GUDID distribution status
In Commercial Distribution

Similar devices

Other devices filed under FDA product code JOW (Sleeve, Limb, Compressible).

Other devices from Zenith Technical Innovations, LLC.

See all devices from Zenith Technical Innovations, LLC. →

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (12, all answered No)