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ThermaZone

FDA UDI

Class II (US FDA UDI)

by Innovative Medical Equipment

Identity

Trade Name
ThermaZone FDA UDI
Generic Name
Circulating-fluid localized thermal therapy system pack, reusable FDA UDI
Device Name
ThermaZone Range of Motion (ROM) Knee Brace with Advanced Heating / Cooling Therapy FDA UDI
Model / Reference
003-47 FDA UDI
Description
ThermaZone Range of Motion (ROM) Knee Brace with Advanced Heating / Cooling Therapy FDA UDI

Identifiers

Catalog Number
003-47 FDA UDI
Primary DI / UDI-DI
00854682001950 FDA UDI
FDA Product Code
ILO FDA UDI
ITM FDA UDI
GMDN Term
Circulating-fluid localized thermal therapy system pack, reusable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
890.5720 FDA UDI
890.3475 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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Knee support orthosisCirculating-fluid localized thermal therapy system pack, reusable

ThermaZone by Innovative Medical Equipment — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Circulating-fluid localized thermal therapy system pack, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Innovative Medical Equipment

Sources (1)

  • FDA UDI 43bd83e7-0e6b-4fbc-aec7-1ba40012dd52 36 fields · synced May 31, 2026