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Kelvi

FDA UDI

Class II (US FDA UDI)

by Hypothermia Devices, Inc.

Identity

Trade Name
Kelvi FDA UDI
Generic Name
Circulating-fluid localized thermal therapy system FDA UDI
Device Name
Kelvi Shoulder Pro Smart Wrap FDA UDI
Model / Reference
KLV20001 FDA UDI
Description
Kelvi Shoulder Pro Smart Wrap FDA UDI

Identifiers

Primary DI / UDI-DI
00850001185028 FDA UDI
FDA Product Code
ILO FDA UDI
GMDN Term
Circulating-fluid localized thermal therapy system 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

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

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Circulating-fluid localized thermal therapy system

Kelvi by Hypothermia Devices, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Circulating-fluid localized thermal therapy system.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Hypothermia Devices, Inc.

Sources (1)

  • FDA UDI 134a9e14-c1f6-414c-9871-6379dab2f030 35 fields · synced May 30, 2026