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Mind+Body Care

FDA UDI

Class II (US FDA UDI)

by Kaz Usa, Inc.

Identity

Trade Name
Mind+Body Care FDA UDI
Generic Name
External electric-heating core temperature regulation system pad FDA UDI
Device Name
Mind+Body Care Spa WrapAround Pain relief for the Entire Body, 24" X 54”, 2 Hour auto shut-off, 10 foot cord. SmartHeat Technology with 3 heat settings. FDA UDI
Model / Reference
HEW3000 FDA UDI
Description
Mind+Body Care Spa WrapAround Pain relief for the Entire Body, 24" X 54”, 2 Hour auto shut-off, 10 foot cord. SmartHeat Technology with 3 heat settings. FDA UDI

Identifiers

Primary DI / UDI-DI
00328785000238 FDA UDI
FDA Product Code
IRT FDA UDI
GMDN Term
External electric-heating core temperature regulation system pad FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
890.5740 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

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: External electric-heating core temperature regulation system pad

Mind+Body Care by Kaz Usa, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as External electric-heating core temperature regulation system pad.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Kaz Usa, Inc.

Sources (1)

  • FDA UDI d18474fe-cc17-420b-aa60-c09eca42f48a 34 fields · synced May 30, 2026