Identity
- Trade Name
- Therm-X FDA UDI
- Generic Name
- Inflatable hot/cold therapy pack/electric pump FDA UDI
- Device Name
- Therm-X Pro FDA UDI
- Model / Reference
- Therm-X Pro FDA UDI
- Description
- Therm-X Pro FDA UDI
Identifiers
- Catalog Number
- TX0001 FDA UDI
- Primary DI / UDI-DI
- 00850001096003 FDA UDI
- 510(k) Number
- K181149 FDA UDI
- FDA Product Code
- JOW FDA UDIILO FDA UDIIRP FDA UDI
- GMDN Term
- Inflatable hot/cold therapy pack/electric pump FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.5800 FDA UDI890.5720 FDA UDI890.5650 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Category: Inflatable hot/cold therapy pack/electric pump
Therm-X by Zenith Technical Innovations, LLC. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Inflatable hot/cold therapy pack/electric pump.
- BREG — Breg, Inc. · Class II
- BREG — Breg, Inc. · Class II
- BREG — Breg, Inc. · Class II
- BREG — Breg, Inc. · Class II
- Squid Rx — Portable Therapeutix · Class I
- Squid — Portable Therapeutix · Class I
- Bio Compression Systems Cryo Insert Large - Black — BIO COMPRESSION SYSTEMS, INC. · Class II
- Squid Go — Portable Therapeutix · Class I
Cleared under the same submission
K181149 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Zenith Technical Innovations, LLC.
Sources (1)
- FDA UDI 655c3e24-be07-4cb9-89f9-aec08bfd03ae 36 fields · synced Jun 8, 2026