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Penguin Cold Therapy®

FDA UDI

Class II (US FDA UDI)

by Gentherm Medical, LLC

Identity

Trade Name
Penguin Cold Therapy® FDA UDI
Generic Name
Circulating-fluid localized thermal therapy system control unit FDA UDI
Device Name
Cold Therapy Device FDA UDI
Model / Reference
707 115V FDA UDI
Description
Cold Therapy Device FDA UDI

Identifiers

Catalog Number
86245 FDA UDI
Primary DI / UDI-DI
10613031862454 FDA UDI
FDA Product Code
ILO FDA UDI
GMDN Term
Circulating-fluid localized thermal therapy system control unit FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
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

No

FDA UDI

Over-the-Counter

Yes

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

Yes

FDA UDI

Dimensions & Sizes

Size
Height — 28.6 Centimeter FDA UDI
Height — 11.25 Inch FDA UDI
Width — 24.8 Centimeter FDA UDI
Width — 9.75 Inch FDA UDI
Length — 40.6 Centimeter FDA UDI
Length — 16 Inch FDA UDI
Weight — 3 Kilogram FDA UDI
Weight — 6.6 Pound FDA UDI

Category: Circulating-fluid localized thermal therapy system control unit

Penguin Cold Therapy® by Gentherm Medical, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Circulating-fluid localized thermal therapy system control unit.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Gentherm Medical, LLC

Sources (1)

  • FDA UDI 5fbb8b94-5db8-4fe2-8832-550aaa5c1348 37 fields · synced May 31, 2026