Product Code: IMD FDA class 1 21 CFR 890.5710

Pack, Hot Or Cold, Disposable

Physical Medicine

A Disposable Hot or Cold Pack is a single-use Physical Medicine thermal therapy product that provides either heat (through an exothermic chemical reaction) or cold (through an endothermic chemical reaction) for temporary localized pain relief, reduction of inflammation, or muscle relaxation. It is classified as FDA Class 1, the lowest risk category, subject only to general controls with no premarket submission required. The product code is IMD, regulated under 21 CFR 890.5710, within the Physical Medicine medical specialty.

View on FDA

510(k)s

FEI Numbers

377

Registration Numbers

377

Unique Applicants

Years Active

Basic Information

Product Code: IMD
Device Class: FDA class 1
Regulation Number: 890.5710
Medical Specialty: Physical Medicine
Review Panel: PM
Submission Type: 4

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✗

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 82 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K221653	InfaTherm Disposable Infant Warming Mattress	Oct 06, 2022	Substantially Equivalent	International Biomedical
K163295	Infant Transport Mattress Warmer with Disc	Jul 24, 2017	Substantially Equivalent	Rapid Aid Corp.
K112547	NEO NEST	Mar 06, 2012	Substantially Equivalent	Denovo Proucts, LLC
K082087	EYEFEEL OPHTHALMIC WARMER	Sep 11, 2008	Substantially Equivalent	Bio-Lipid, Inc.
K071710	BENGAY (R) HEAT THERAPY, PAIN RELIEVING PATCHES/PADS (VARIOUS)	Aug 14, 2007	Substantially Equivalent	Johnson & Johnson Consumer Products, Inc.
K021843	EYEFEEL OPHTHALMIC WARMER	Sep 03, 2002	Substantially Equivalent	Bio-Lipid, Inc.
K982652	ALLEGIANCE PORTA-WARM MATTRESS	Jan 21, 1999	Substantially Equivalent	Allegiance Healthcare Corp.
K980509	DEROYAL INDUSTRIES, INC. INFANT TRANSPORT MATTRESS	Feb 26, 1998	Substantially Equivalent	Deroyal Industries, Inc.
K974190	CP&S INSTANT COLD PACK LIMB KIT TRANSPORTER	Nov 19, 1997	Substantially Equivalent	Consolidated Products & Services, Inc.
K973770	ALLEGIANCE KWIK HEAT WARM PERINEAL PACK	Nov 13, 1997	Substantially Equivalent	Allegiance Healthcare Corp.
K970399	KWIK KOLD PERI COLD PACK (CATALOG NUMBER TBD)	Apr 03, 1997	Substantially Equivalent	Allegiance Healthcare Corp.
K963689	RECOVER ADULT VEIN WARMER	Dec 12, 1996	Substantially Equivalent	Florida Medical Industries, Inc.
K963768	INSTANT HOT PACKS	Nov 25, 1996	Substantially Equivalent	Kick Ice, Inc.
K963666	INSTANT COLD PACK	Oct 30, 1996	Substantially Equivalent	Kick Ice, Inc.
K963220	TEMPRA COLD PACK, REORDER NO. TC150	Oct 10, 1996	Substantially Equivalent	Tempo Technology, Inc.
K961176	OMNI COLD GEL PACKS	Sep 04, 1996	Substantially Equivalent	Omni Therm, Inc.
K955788	IMNI HOT PACKS	Sep 04, 1996	Substantially Equivalent	Omni Therm, Inc.
K951033	ANDELA DYNAMIC COOLING DEVICE	Aug 15, 1996	Substantially Equivalent	Candela Laser Corp.
K960624	CERTI COOL INSTANT COLD COMPRESS	May 06, 1996	Substantially Equivalent for Some Indications	Certified Safety Mfg., Inc.
K954877	OMNI COLD GEL PACKS	Feb 13, 1996	Substantially Equivalent for Some Indications	Omni Therm, Inc.
K953442	RESTORE, THERMACELLS (HOT PACK I)	Oct 31, 1995	Substantially Equivalent for Some Indications	Neal Dunning Assoc., Inc.
K953542	COLDGEL	Oct 30, 1995	Substantially Equivalent for Some Indications	Prism Technologies, Inc.
K953541	INSTANT COLDGEL	Oct 05, 1995	Substantially Equivalent	Prism Technologies, Inc.
K950680	INFANT HEEL WARMER	Aug 23, 1995	Substantially Equivalent for Some Indications	Baxter Healthcare Corp
K951383	TEMPRA HEAT PACK	Jun 01, 1995	Substantially Equivalent for Some Indications	Tempra Technology, Inc.
K941245	POLY-MEDICS HEAT PACK	May 02, 1994	Substantially Equivalent	Biomet, Inc.
K936084	OMNI WARM GEL PACKS	Mar 31, 1994	Substantially Equivalent	Omni Therm, Inc.
K940336	CERTI HEAT INSTANT HEAT COMPRESS	Mar 07, 1994	Substantially Equivalent	Certified Safety Mfg., Inc.
K935569	INSTANT HOT OR COLD DISPOSABLE PACK	Mar 07, 1994	Substantially Equivalent	Cryopak Industries, Inc.
K934631	TRANSWARMER	Feb 03, 1994	Substantially Equivalent	Prism Technologies, Inc.
K934673	KACEY DISPOSABLE INFANT HEEL WARMER	Feb 02, 1994	Substantially Equivalent	K & C Medical, Inc.
K920760	PERI-K PAD COLD PACK	Jul 29, 1993	Substantially Equivalent	Baxter Healthcare Corp
K926590	ANAGO DISPOSABLE INSTANT COLD PACK	May 26, 1993	Substantially Equivalent	Anago, Inc.
K926589	ANAGO WARM PACK	May 26, 1993	Substantially Equivalent	Anago, Inc.
K926137	ANAGO FEM-COOL/FEM-COOL PETITE	May 26, 1993	Substantially Equivalent	Anago, Inc.
K920252	CURAD KID SIZE INSTANT COLD PACK	Feb 11, 1992	Substantially Equivalent	Kendall Healthcare Products Co. Div.Of Tyco Health
K912715	INSTANT WARM GEL PACK	Oct 02, 1991	Substantially Equivalent	Prism Technologies, Inc.
K904819	SHUR-LOCK ICE WRAP SYSTEM	Dec 06, 1990	Substantially Equivalent	Conco Medical Co.
K902839	LIBERTY HOT PACK AND LIBERTY KOLD PACK	Jul 25, 1990	Substantially Equivalent	Liberty Ent.
K901834	INSTANT ICE PACK	May 03, 1990	Substantially Equivalent	Impact Packaging Corp.
K901778	3M HEAT COMFORT PORTABLE SELF-HEATING PAD	May 01, 1990	Substantially Equivalent	3M Company
K895860	MEDI-PACK	Jan 02, 1990	Substantially Equivalent	Heatmax Mfg., Inc.
K894926	STAT-PAD	Sep 05, 1989	Substantially Equivalent	Hettel Accessories, Inc.
K890924	THERMO-PACK	Mar 14, 1989	Substantially Equivalent	Medical Manufacturers, Inc.
K890554	CP&S DISPOSABLE INSTANT SUPER HOT COMPRESS	Feb 13, 1989	Substantially Equivalent	Consolidated Products & Services, Inc.
K890553	CP&S DISPOSABLE INSTANT COLD COMPRESS	Feb 13, 1989	Substantially Equivalent	Consolidated Products & Services, Inc.
K883966	HARE COLD PACK	Sep 30, 1988	Substantially Equivalent	Dyna Industries, Inc.
K880871	GRABBER WARM PACK/MINI MINI HEATER/FOOT HEATER	May 20, 1988	Substantially Equivalent	John Wagner Associates, Inc.
K873364	HYPERTHERM TECHNOLOGIES' HEAT COMPRESS	Nov 17, 1987	Substantially Equivalent	Hypertherm Technologies, Inc.
K871168	INSTANT COLD COMPRESS, CHEMICAL TYPE	Apr 06, 1987	Substantially Equivalent	Lexington Industries
K871114	INSTANT HEAT COMPRESS, CHEMICAL TYPE	Mar 25, 1987	Substantially Equivalent	Lexington Industries
K870832	OXY-THERM	Mar 12, 1987	Substantially Equivalent	M.D. Intl., Inc.
K863507	PHYSI. & NURSES BRAND INSTANT KOLD & HOT KOMPRESS	Sep 19, 1986	Substantially Equivalent	Physician & Nurses Mfg. Corp.
K860444	MAZING HEAT DISPOSABLE WARM PACK	Feb 27, 1986	Substantially Equivalent	Leebryan Intl.
K853148	HOT OR HEAT PACK	Sep 25, 1985	Substantially Equivalent	Matrix Intl.
K853045	ALLY PORTABLE NOT PACK/PAD DISPOSABLE	Sep 06, 1985	Substantially Equivalent	Actin International, Inc.
K852610	HOT PACK	Aug 12, 1985	Substantially Equivalent	Oriental Medical Supplies, Inc.
K850566	MARUKYR-BAN / HOT OR HEAT PACK	May 29, 1985	Substantially Equivalent	Oriental Medical Supplies, Inc.
K850637	EXOTHERMIC HEATING PAD	Apr 25, 1985	Substantially Equivalent	Travenol Laboratories, S.A.
K844224	EIXO THERMUS HEATING PADS	Nov 23, 1984	Substantially Equivalent	Eixo Thermus
K820906	SPENCO CRYOPRESS	May 13, 1982	Substantially Equivalent	Spenco Medical Corp.
K821046	COMPRES PORTABLE HEAT PADS	Apr 29, 1982	Substantially Equivalent	S.C. Johnson & Son, Inc.
K820359	HOT MINI 15 & HOT MINI 24	Mar 08, 1982	Substantially Equivalent	Hot Mini International, Inc.
K820282	ACE BRAND INSTANT COLD PACK	Feb 12, 1982	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K813628	BK-7182 INSTANT COLD PACK	Jan 19, 1982	Substantially Equivalent	Fred Sammons, Inc.
K811803	JAPANESE HOTZIE	Jul 31, 1981	Substantially Equivalent	Consolidated Health & Sports Prod.
K811206	SELF HEATING DISPOSABLE HEAT PAD	May 21, 1981	Substantially Equivalent	Ensar Corp.
K810693	CURITY PERINEAL COLD PACK	Mar 26, 1981	Substantially Equivalent	The Kendal Co.
K810692	CURITY PERINEAL WARM PACK	Mar 26, 1981	Substantially Equivalent	The Kendal Co.
K810633	WONDER WARMER	Mar 26, 1981	Substantially Equivalent	Montvale Products, Inc.
K802252	HOT CYCLE, A CHEMICAL TYPE HOT PACK	Oct 03, 1980	Substantially Equivalent	Signal West
K790993	INSTANT HOT & COLD PACKS	Sep 07, 1979	Substantially Equivalent	Chase Mfg. Co.
K791675	KWICK KOOLER	Sep 04, 1979	Substantially Equivalent	Stahlex Corp.
K790480	TULANE HEAT-PACK	Apr 03, 1979	Substantially Equivalent	Tulane
K780426	BODY WARMER	Apr 27, 1978	Substantially Equivalent	Q-Matic Corp.
K780603	COLD PACK	Apr 21, 1978	Substantially Equivalent	Abco Dealers, Inc.
K780279	ICE-PAK, PDI	Apr 10, 1978	Substantially Equivalent	Nice-Pak Products, Inc.
K780014	COLD CYCLE, CHEMICAL COLD PACK	Feb 21, 1978	Substantially Equivalent	Signal West
K771660	KWICK KOOLER	Nov 07, 1977	Substantially Equivalent	World Trade Assoc.
K770505	SHAKE-N-WARM	Apr 05, 1977	Substantially Equivalent	Signal West
K760706	MUL-T-PAD	Oct 06, 1976	Substantially Equivalent	Gaymar Industries, Inc.
K760441	BODY WARMER (SHAKE-N-WARM)	Sep 16, 1976	Substantially Equivalent	Yamada Co., Ltd of Japan