SpeedHeat

FDA UDI

Class II (US FDA UDI)

by Inspiration Healthcare Group Plc

Identity

Trade Name: SpeedHeat FDA UDI
Generic Name: Electric pad whole-body heating system FDA UDI
Device Name: SHP001 Pad FDA UDI
Model / Reference: SHP001 FDA UDI
Description: SHP001 Pad FDA UDI

Identifiers

Primary DI / UDI-DI: 05060195340379 FDA UDI
FDA Product Code: IRT FDA UDI
GMDN Term: Electric pad whole-body heating system 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

Yes

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

Yes

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

MRI Safety

MR Unsafe FDA UDI

Category: Electric pad whole-body heating system

SpeedHeat by Inspiration Healthcare Group Plc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Inspiration Healthcare Group Plc

Sources (1)

FDA UDI cd852e24-d7d7-4df0-834b-daadc4ce967a 34 fields · synced Jun 1, 2026