Product Code: IRT FDA class 2 21 CFR 890.5740

Pad, Heating, Powered

Physical Medicine

A powered heating pad is an electrically operated pad that provides controlled therapeutic heat to localized body areas for relief of muscle pain, stiffness, and related musculoskeletal conditions. It is classified as FDA Class 2, indicating moderate risk and requiring 510(k) premarket notification. The product code is IRT, regulated under 21 CFR 890.5740, within the Physical Medicine medical specialty.

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510(k)s

FEI Numbers

259

Registration Numbers

259

Unique Applicants

Years Active

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Basic Information

Product Code: IRT
Device Class: FDA class 2
Regulation Number: 890.5740
Medical Specialty: Physical Medicine
Review Panel: PM
Submission Type: 4

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✗

Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 42 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K250047	bite away two	Sep 12, 2025	Substantially Equivalent	mibeTec GmbH
K220514	bite away neo	Jun 23, 2022	Substantially Equivalent	mibeTec GmbH
K160943	Bite Away	Aug 26, 2016	Substantially Equivalent	Riemser Pharma
K142228	Heated Eye Pad	Feb 09, 2015	Substantially Equivalent	Digital Heat Corporation
K133981	AVACEN 100	Aug 15, 2014	Substantially Equivalent	Avacen, Inc.
K111273	FIR HEAT THERAPHY SYSYEMS	Nov 08, 2011	Substantially Equivalent	Shenzhen Anpan Technology Co., Ltd.
K072534	BIO-MAT 2000	Feb 08, 2008	Substantially Equivalent	Richway Intl., Inc.
K963887	PT-PAC PORTABLE HEATING PAD	Mar 31, 1997	Substantially Equivalent	Anthony A. Chiurco
K963824	LI'S ITCH STOPPER	Dec 12, 1996	Substantially Equivalent	Hontech Foundation For Medical Technology
K962195	HEALTH O METER ELECTRIC HEATING PADS MODELS EHP2, EHP3	Nov 27, 1996	Substantially Equivalent	Sunbeam Health Division
K962252	HEALTH O METER ELECTRIC HEATING PAD W/MASSAGE MODEL EHP4	Nov 25, 1996	Substantially Equivalent	Sunbeam Health Division
K962038	PES HOT/COLD COMPRESS	Nov 13, 1996	Substantially Equivalent	Princeton Electronic Systems, Inc.
K924970	FEMININE HEAT WRAP	Oct 03, 1994	Substantially Equivalent for Some Indications	Conair Corp.
K925630	ELASTOPLAST HEAT PLASTER	Feb 25, 1994	Substantially Equivalent	Beiersdorf, Inc.
K925820	ARTHRITIC HEAT WRAP	Feb 02, 1994	Substantially Equivalent	Conair Corp.
K924885	KING SIZE HEAT PAD	Oct 12, 1993	Substantially Equivalent	Conair Corp.
K924800	MOSIST HEAT PAD WITH AUTOMATIC OFF	Oct 12, 1993	Substantially Equivalent	Conair Corp.
K924799	MOIST HEAT PAD	Oct 12, 1993	Substantially Equivalent	Conair Corp.
K923396	THERMODYN	May 26, 1993	Substantially Equivalent	Nemectron Medical, Inc.
K922089	PNEUMATHERM	Feb 23, 1993	Substantially Equivalent	National Pain Institute
K915241	SPORTS HEAT WRAP	Dec 20, 1991	Substantially Equivalent	Conair Corp.
K911195	DUNLAP HEAT PAD	Aug 12, 1991	Substantially Equivalent	Home Healthcare Products, Inc.
K903321	SANDBOX I, SANDBOX II, SANDBOX JR.	Feb 19, 1991	Substantially Equivalent	Sandbox Ent.
K902895	INFRASSAGE MASSAGER	Jul 25, 1990	Substantially Equivalent	Conair Corp.
K881800	BCS NO. 1, BODY CARE SYSTEM	Nov 16, 1988	Substantially Equivalent	M & A Vertrieb, Liske Und Methling GM
K882151	PORT-O-HEAT, MODEL 0100	Nov 04, 1988	Substantially Equivalent	Arthotronics, Inc.
K881862	THERMO-BODY-WRAP SYSTEM	Oct 13, 1988	Substantially Equivalent	Thermo Body Wrap Systems, Inc.
K873576	HUCHEL BODYLINER	Jan 19, 1988	Substantially Equivalent	Hans-Juergen Huchel
K873254	THERMOWRAP, A/K/A/, THERMAL WRAP	Dec 11, 1987	Substantially Equivalent	Family Sun Tanning
K862106	FORMOSTAR	Aug 21, 1986	Substantially Equivalent	Lmv, Liske & Methling, GmbH
K861383	SOLEX THERAPEUTIC PAD	Apr 18, 1986	Substantially Equivalent	Intl. Diathermics Research, Inc.
K852637	THERMO TRIM	Nov 20, 1985	Substantially Equivalent	Suntec Health & Fitness Group, Inc.
K852604	MUSCLE MINDER: HEAT WRAP W/ HOT + COLD PACK	Aug 12, 1985	Substantially Equivalent	Clairol, Inc.
K851237	THERMOPHORE ELECTRIC FOMENTATION UNIT	Jul 29, 1985	Substantially Equivalent	Battle Creek Equipment Co.
K841697	HYDRO-THERO PAD	May 09, 1984	Substantially Equivalent	Maddak, Inc.
K841100	HP-20, 30, 40, 50 & 60	Mar 23, 1984	Substantially Equivalent	Associated Mills, Inc.
K823301	MICROPAD	Dec 03, 1982	Substantially Equivalent	Fia Man Co.
K821692	PASSIVE HEAT PADS	Jul 13, 1982	Substantially Equivalent	Biotone International, Inc.
K801081	DELUXE HEAT WRAP/COLD WRAP	May 14, 1980	Substantially Equivalent	The Gillette Company
K791154	THERMAL CONDITIONING SYSTEM	Oct 09, 1979	Substantially Equivalent	Acurex Aerotherm
K790374	GILLETTE HEAT WRAP	Apr 10, 1979	Substantially Equivalent	The Gillette Company
K770686	THERATHERM	Jul 14, 1977	Substantially Equivalent	Electro Therapeutic Devices, Inc.