Avacen

FDA UDI

Class II (US FDA UDI)

by Avacen Medical, Inc

Identity

Trade Name: AVACEN FDA UDI
Generic Name: Electric pad localized-body heating system FDA UDI
Device Name: The AVACEN HOME XL consists of a control panel, temperature controlled raised thermal transfer pad, and a vacuum chamber. The AVACEN HOME XL is designed to comfortably and noninvasively apply dry heat to the hand for the temporary relief of minor aches and pains. The user places their hand into the AVACEN HOME XL for approximately 10 to 60 minutes per treatment session. A vacuum pump creates a slight vacuum (25 to 35mm Hg) on the hand, which accelerates the transfer of heat. FDA UDI
Model / Reference: AVACEN HOME XL 5-YEAR FDA UDI
Description: The AVACEN HOME XL consists of a control panel, temperature controlled raised thermal transfer pad, and a vacuum chamber. The AVACEN HOME XL is designed to comfortably and noninvasively apply dry heat to the hand for the temporary relief of minor aches and pains. The user places their hand into the AVACEN HOME XL for approximately 10 to 60 minutes per treatment session. A vacuum pump creates a slight vacuum (25 to 35mm Hg) on the hand, which accelerates the transfer of heat. FDA UDI

Identifiers

Primary DI / UDI-DI: 00862800000396 FDA UDI
510(k) Number: K133981 FDA UDI
FDA Product Code: IRT FDA UDI
GMDN Term: Electric pad localized-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

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Electric pad localized-body heating system

Avacen by Avacen Medical, Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K133981 also covers:

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: Avacen Medical, Inc

Sources (1)

FDA UDI ea104b60-b95e-4974-bbac-6e66f012b00a 36 fields · synced May 30, 2026