Identity
- Trade Name
- Therm-X FDA UDI
- Generic Name
- Inflatable hot/cold therapy pack/electric pump FDA UDI
- Device Name
- Therm-X Garment - Elbow EUDAMEDTherm-X Elbow Garment FDA UDI
- Model / Reference
- TX0103 EUDAMEDTherm-X Elbow Garment FDA UDI
- Description
- Therm-X Elbow Garment FDA UDI
Identifiers
- Catalog Number
- TX0103 FDA UDI
- Primary DI / UDI-DI
- 00850001096423 EUDAMED00850001096058 FDA UDI
- Basic UDI-DI
- 08500010960103B9 EUDAMED
- Direct Marketing DI
- 00850001096423 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
No
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 - Elbow by Zenith Technical Innovations, LLC. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 08500010960103B9 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Zenith Technical Innovations, LLC.
- EUDAMED SRN
- US-MF-000047832
- Authorised Representative
- MedEnvoy Global BV NL-AR-000024028
Sources (2)
- EUDAMED 715e71b4-3a3f-4017-9fdd-e6650b39fc37 61 fields · synced Jul 10, 2026
- FDA UDI aa9edcd3-20ce-460a-91a8-2e44a41a524c 35 fields · synced May 30, 2026