Identity
- Trade Name
- Therm-X FDA UDI
- Generic Name
- Inflatable hot/cold therapy pack/electric pump FDA UDI
- Device Name
- Therm-X Garment - Hand EUDAMEDTherm-X Hand Garment FDA UDI
- Model / Reference
- TX0112 EUDAMEDTherm-X Hand Garment FDA UDI
- Description
- Therm-X Hand Garment FDA UDI
Identifiers
- Catalog Number
- TX0112 FDA UDI
- Primary DI / UDI-DI
- 00850001096492 EUDAMED00850001096355 FDA UDI
- Basic UDI-DI
- 08500010960112BA EUDAMED
- Direct Marketing DI
- 00850001096492 EUDAMED
- FDA Product Code
- JOW FDA UDIILO FDA UDIIRP FDA UDI
- EMDN Code
- Z120616 ELECTROMECHANICAL SYSTEMS FOR PHYSICAL THERAPY EUDAMED
- GMDN Term
- Inflatable hot/cold therapy pack/electric pump FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 870.5800 FDA UDI890.5720 FDA UDI890.5650 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
Yes
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Therm-X Garment - Hand by Zenith Technical Innovations, LLC. — Class I — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
United States Active
FDA_510K
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K190854 | Class I | Active |
| FDA 510(k) | United States | FDA_510K | K231912 | Class I | Active |
| FDA 510(k) | United States | FDA_510K | K193550 | Class I | Active |
| EUDAMED | European Union | CE/MDR | 08500010960112BA | Class I | Active |
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Manufacturer
- Manufacturer
- Zenith Technical Innovations, LLC.
- EUDAMED SRN
- US-MF-000047832
- Authorised Representative
- MedEnvoy Global BV NL-AR-000024028
Sources (3)
- EUDAMED 796c8b2d-c133-435e-b4bc-ce5ece08610a 61 fields · synced Jun 19, 2026
- FDA UDI 0468f39d-b568-494a-ab31-0ff2d700a73e 36 fields · synced May 30, 2026
- FDA 510(k) K190854 1 fields · synced May 18, 2026