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Therm-X

FDA UDI

Class II (US FDA UDI)

by Zenith Technical Innovations, LLC.

Identity

Trade Name
Therm-X FDA UDI
Generic Name
Inflatable hot/cold therapy pack/electric pump FDA UDI
Device Name
Therm-X Butterfly Knee Small, SPU FDA UDI
Model / Reference
Therm-X Butterfly Knee Small, SPU FDA UDI
Description
Therm-X Butterfly Knee Small, SPU FDA UDI

Identifiers

Catalog Number
TX0315 FDA UDI
Primary DI / UDI-DI
00850001096379 FDA UDI
510(k) Number
K231912 FDA UDI
K240125 FDA UDI
FDA Product Code
IRP FDA UDI
JOW FDA UDI
ILO FDA UDI
GMDN Term
Inflatable hot/cold therapy pack/electric pump FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
890.5650 FDA UDI
870.5800 FDA UDI
890.5720 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.

Cleared under the same submission

K231912 also covers:

K240125 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Zenith Technical Innovations, LLC.

Sources (1)

  • FDA UDI 22e7c3f4-3d71-44b4-a8e1-4c00653e2d5e 36 fields · synced May 30, 2026