Identity
- Trade Name
- Therm-X FDA UDI
- Generic Name
- Inflatable hot/cold therapy pack/electric pump FDA UDI
- Device Name
- Therm-X Garment - XL Shoulder EUDAMEDTherm-X XL Shoulder Garment FDA UDI
- Model / Reference
- TX0110 EUDAMEDTherm-X XL Shoulder Garment FDA UDI
- Description
- Therm-X XL Shoulder Garment FDA UDI
Identifiers
- Catalog Number
- TX0110 FDA UDI
- Primary DI / UDI-DI
- 00850001096454 EUDAMED00850001096300 FDA UDI
- Basic UDI-DI
- 08500010960110B6 EUDAMED
- Direct Marketing DI
- 00850001096454 EUDAMED
- FDA Product Code
- IRP FDA UDIJOW FDA UDIILO 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
- 890.5650 FDA UDI870.5800 FDA UDI890.5720 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 - XL Shoulder 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 | 08500010960110B6 | 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 c9382d24-9a44-4ad5-b4ad-6cf305f59e86 61 fields · synced Jun 17, 2026
- FDA UDI 56ca0645-5e90-4ed6-a198-bb7ce28a6026 35 fields · synced May 29, 2026