Product Code: ILO FDA class 2 21 CFR 890.5720

Pack, Hot Or Cold, Water Circulating

Physical Medicine

A Water Circulating Hot or Cold Pack is a Physical Medicine thermal therapy device that uses temperature-controlled circulating water through a pad or wrap applied to the body, providing sustained therapeutic heating or cooling for pain relief, inflammation management, or rehabilitation. It is classified as FDA Class 2, representing moderate risk, meaning it requires a 510(k) premarket notification demonstrating substantial equivalence to a predicate device before marketing. The product code is ILO, regulated under 21 CFR 890.5720, within the Physical Medicine medical specialty.

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510(k)s

FEI Numbers

123

Registration Numbers

123

Unique Applicants

Years Active

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Basic Information

Product Code: ILO
Device Class: FDA class 2
Regulation Number: 890.5720
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 93 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K213097	Armory Motion	Jun 10, 2022	Substantially Equivalent	Pain Management Technologies, Inc.
K083008	COOLSKIN	Jun 10, 2009	Substantially Equivalent	Elbio Co., Ltd.
K073675	T-PUMP LOCALIZED TEMPERATURE THERAPY PUMP	May 08, 2008	Substantially Equivalent	Gaymar Industries, Inc.
K072152	JUNIPER CLN1 DERMAL COOLING DEVICE	Sep 07, 2007	Substantially Equivalent	Juniper Medical, Inc.
K070402	MODIFICATION TO POLAR CARE 500	Mar 29, 2007	Substantially Equivalent	Breg, Inc.
K040317	IVC SYSTEM	May 07, 2004	Substantially Equivalent	Mark H. Friedman
K973023	INCARE HOT/ICE SYSTEM FOOT/ANKLE BLANKET	Nov 03, 1997	Substantially Equivalent	Hollister, Inc.
K970197	HTP-1500 LOCALIZED HEAT THERAPY PUMP	Sep 10, 1997	Substantially Equivalent	Adroit Medical Systems, Inc.
K964799	ARTROTHERM CRYOTHERAPY AND THERNOTHERAPY	Aug 29, 1997	Substantially Equivalent	Ormed GmbH
K964354	ARTOCOOL-S WATER CIRCULATING COLD PACK	Aug 29, 1997	Substantially Equivalent	Ormed GmbH
K964710	BLEDSOE COLD CONTROL	May 09, 1997	Substantially Equivalent	Med Technology, Inc.
K970533	MODEL 1100 COLD THERAPY DEVICE	Apr 15, 1997	Substantially Equivalent	Smith & Nephew, Inc.
K962983	STERILE SOFT-TEMP	Jan 10, 1997	Substantially Equivalent	Adroit Medical Systems, Inc.
K964057	INCARE HOT/ICE SYSTEM SHOULDER BLANKET	Dec 31, 1996	Substantially Equivalent	Hollister, Inc.
K964006	INCARE HOT/ICE SYSTEM BLANKETS (VARIOUS SIZES AND SHAPES)	Dec 31, 1996	Substantially Equivalent	Hollister, Inc.
K963596	POLAR CARE 300	Dec 04, 1996	Substantially Equivalent	Breg, Inc.
K962537	INCARE HOT/ICE LITE MACHINE	Nov 27, 1996	Substantially Equivalent	Hollister, Inc.
K961621	THERAPY CONCEPTS WATER CIRCULATING TREATMENT SYSTEM	Oct 31, 1996	Substantially Equivalent	Therapy Concepts, Inc.
K961425	BIO COMPRESSION COLD FLO, SINGLE CHAMBER INTERMITTENT AND MULTI-CHAMBER SEQUENTIAL MODELS	Oct 28, 1996	Substantially Equivalent	Bio Compression Systems, Inc.
K963261	EBI THERMAL THERAPY SYSTEM	Sep 27, 1996	Substantially Equivalent	Electro-Biology, Inc.
K961855	POLAR CARE (MODEL 500/50000)	Aug 09, 1996	Substantially Equivalent	Breg, Inc.
K955529	CRYTRON SYSTEM	Jun 10, 1996	Substantially Equivalent	Mark H. Friedman
K955326	SPORTS CONTRAST THERAPY SYSTEM ST 7000	Apr 10, 1996	Substantially Equivalent for Some Indications	Burke Neutech, Inc.
K955057	MODEL 1100 COLD THERAPY DEVICE	Mar 08, 1996	Substantially Equivalent for Some Indications	Smith and Nephew Donjoy, Inc.
K954095	MEDICOOL (MODIFICATON)	Mar 06, 1996	Substantially Equivalent for Some Indications	Microclimate Systems, Inc.
K945853	THERMOTEK H-300	Oct 05, 1995	Substantially Equivalent for Some Indications	Thermotek, Inc.
K953532	EBICE	Oct 04, 1995	Substantially Equivalent	Electro-Biology, Inc.
K950395	THERMOCOOL SYSTEM	Aug 18, 1995	Substantially Equivalent for Some Indications	Zimmer, Inc.
K950711	T-350 THERAPEUTIC COOLING MACHINE	Jul 06, 1995	Substantially Equivalent	Thermotek, Inc.
K945468	T-300 COOLER	Jun 19, 1995	Substantially Equivalent	Temptek, Inc.
K943497	CONTRAST 7000 THERAPY SYSTEM	Jun 07, 1995	Substantially Equivalent	Burke Neutech, Inc.
K945467	BABYTHERM 8000 WB	Apr 28, 1995	Substantially Equivalent	Drager, Inc.
K934262	HPRH HOSPITAL PATIENT RADIANT HEATER	Apr 18, 1995	Substantially Equivalent for Some Indications	Marley Electric Heating Co.
K945399	DELTA THERM COLD THERAPY SYSTEM	Mar 07, 1995	Substantially Equivalent for Some Indications	Deltatherm
K945067	EBICE	Feb 09, 1995	Substantially Equivalent for Some Indications	Electro-Biology, Inc.
K944447	COOL/HEAT THERAPY APPLICATOR	Feb 09, 1995	Substantially Equivalent for Some Indications	Medical Science Technology, Inc.
K943844	TOTALLY COOL(TM) TC-1	Feb 09, 1995	Substantially Equivalent for Some Indications	Electro Science Technologies, Inc.
K942882	TOTALLY COOL(TM) TC-2	Feb 09, 1995	Substantially Equivalent for Some Indications	Electro Science Technologies, Inc.
K944971	INCARE HOT/ICE COLD THERAPY COOLER	Jan 30, 1995	Substantially Equivalent for Some Indications	Hollister, Inc.
K935841	DR KOOL	Aug 29, 1994	Substantially Equivalent for Some Indications	Toronto Medical Corp.
K940858	THERA COOL HOME UNIT/COOLPAC(AMBU/RESERVIOR UNITS)	Jul 12, 1994	Substantially Equivalent for Some Indications	Innovation Sports, Inc.
K940429	ORTHO TECH CRYOLOGIC SYSTEM	Jul 12, 1994	Substantially Equivalent for Some Indications	Orthopedic Technology, Inc.
K936143	ISOCOMFORTER	Jul 12, 1994	Substantially Equivalent for Some Indications	Isocomforter, Inc.
K940160	TS1000 PORTABLE DISPOSABLE COLD THERAPY SYSTEM	May 27, 1994	Substantially Equivalent	Burke Neutech, Inc.
K930918	HYDROT	May 25, 1994	Substantially Equivalent	Sanker Intl., Inc.
K931203	COOL-AID	Feb 22, 1994	Substantially Equivalent	Seabrook Medical Systems, Inc.
K931843	HOT/ICE SYSTEM STERILE CONFORMABLE/DISP. BLANKETS	Feb 02, 1994	Substantially Equivalent	Hollister, Inc.
K930634	SUR FLO THERMAL THERAPY PADS	Nov 01, 1993	Substantially Equivalent	Buckman Co., Inc.
K926151	LSI6000 THERMAL THERAPY SYSTEM	May 26, 1993	Substantially Equivalent	Burke Neutech, Inc.
K925677	AUTOCHILL ACCESSORY KIT	Apr 14, 1993	Substantially Equivalent	Aircast, Inc.
K923643	MEDICOOL	Mar 31, 1993	Substantially Equivalent	Micromedic Systems
K921540	COOLING/HEATING THERAPY DEVICE	Jul 21, 1992	Substantially Equivalent	Tempacure Home Care
K920581	POLAR PAD (STERILE)	Mar 20, 1992	Substantially Equivalent	Breg, Inc.
K915196	INCARE HOT/ICE SYSTEM 3	Feb 03, 1992	Substantially Equivalent	Hollister, Inc.
K913026	TTU-100THERMAL THERAPY UNIT	Dec 13, 1991	Substantially Equivalent	Danninger Medical Technology, Inc.
K914434	POLAR PADS	Oct 24, 1991	Substantially Equivalent	Breg, Inc.
K914182	GOLDEN THERMAL(R)	Oct 18, 1991	Substantially Equivalent	Seabrook Medical Systems, Inc.
K913729	POLAR PUMP, MODEL 500	Oct 18, 1991	Substantially Equivalent	Breg, Inc.
K912722	HYPER-K HEAT SYSTEM	Sep 11, 1991	Substantially Equivalent	Baxter Healthcare Corp
K911943	CONCEPT MODEL 5200 THERMAL THERAPY SYSTEM	Jul 19, 1991	Substantially Equivalent	Burke, Inc.
K910061	K-MODULE II HEAT THERAPY SYSTEM	Feb 13, 1991	Substantially Equivalent	Baxter Healthcare Corp
K904998	THE BODY COOLER SYSTEM	Jan 14, 1991	Substantially Equivalent	Costa / French
K902269	ELECTRI-COOL(TM) LIQUID-CIRCULAT. THERMAL THERAPY	Jun 21, 1990	Substantially Equivalent	Seabrook Medical Systems, Inc.
K902268	PEDIA-TEMP(TM) LIQUID-CIRCULATING HYPO-HYPERTHERM.	Jun 21, 1990	Substantially Equivalent	Seabrook Medical Systems, Inc.
K900356	THERMOAIRE SPLINT (TM) (TAS)	May 07, 1990	Substantially Equivalent	Life Enhancement Technologies, LLC
K891091	TEMPTEK T-1000 THERAPEUTIC COOLING UNIT	Mar 26, 1990	Substantially Equivalent	Temptek, Inc.
K900355	MARK VII THERMOREGULATION ASSIST SYSTEM	Feb 15, 1990	Substantially Equivalent	Life Enhancement Technologies, LLC
K891603	BODY COOLER OR COOLVEST OR ALPHA BODY COOLER	Jul 25, 1989	Substantially Equivalent	Alpha Rehabilitation Products
K893706	COLD/HOT FLUID RADIATION PAD NEUTECH	Jun 22, 1989	Substantially Equivalent	Burke, Inc.
K891092	TEMPTEK 5010 THERMAL COOLING BLANKET	May 26, 1989	Substantially Equivalent	Temptek, Inc.
K890853	AQUA-PAD FOR MOIST OR DRY HEAT THERAPY	Apr 14, 1989	Substantially Equivalent	Ati
K890852	AQUA-BLANKET HYPER/HYPOHERMIA BLANKET	Apr 14, 1989	Substantially Equivalent	Ati
K891151	COOL 'N HEAT MACHINE	Apr 06, 1989	Substantially Equivalent	Kinetic Concepts, Inc.
K891152	GRAND COOLING MACHINE	Mar 23, 1989	Substantially Equivalent	Kinetic Concepts, Inc.
K884255	CONCEPT CCT-5200, THERMAL THERAPY SYSTEM	Nov 08, 1988	Substantially Equivalent	Concept, Inc.
K883681	DAS SPORT PUMP(TM)	Sep 30, 1988	Substantially Equivalent	D.A. Schulman, Inc.
K882310	DUAL-TEMP(TM) COOLING/WARMING UNIT	Sep 23, 1988	Substantially Equivalent	Seabrook Medical Systems, Inc.
K871963	HOT/ICE DISPOSABLE BLANKET	Jun 26, 1987	Substantially Equivalent	Thermo Temp, Inc.
K871962	HOT/ICE DUAL FUNCTION EQUIPMENT	Jun 26, 1987	Substantially Equivalent	Thermo Temp, Inc.
K852495	CAST-TECH CO. COOLING SYSTEM	Sep 05, 1985	Substantially Equivalent	Cast-Tech Co.
K843146	MICRO-TEMP PUMPS & MICRO-TEMP PADS	Aug 17, 1984	Substantially Equivalent	Seabrook Medical Systems, Inc.
K833564	HOT/ICE DISPOSABLE BLANKET	Nov 28, 1983	Substantially Equivalent	Thermo Temp, Inc.
K832820	MUL-T-BLANKET	Sep 26, 1983	Substantially Equivalent	Gaymar Industries, Inc.
K832819	MUL-T-PAD	Sep 26, 1983	Substantially Equivalent	Gaymar Industries, Inc.
K830757	HOT/ICE	Mar 29, 1983	Substantially Equivalent	Thermo Temp, Inc.
K801301	GOLDEN THERMAL RHINOPLASTY CAST BANDAGE	Jun 20, 1980	Substantially Equivalent	Auric, Inc.
K791162	GELSKIN	Sep 04, 1979	Substantially Equivalent	Spenco Medical Corp.
K780452	THERA-PAK	Jun 21, 1978	Substantially Equivalent	Hydro-Med Products, Inc.
K761254	BAND-AGE ICE-BANDAGE	Feb 24, 1977	Substantially Equivalent	Surgicot, Inc.
K760910	DISPOSABLE K-PADS	Dec 16, 1976	Substantially Equivalent	Gorman Rupp Industries
K760782	TECNOL PATIENT USE ICE PACK	Dec 02, 1976	Substantially Equivalent	Tecnol New Jersey Wound Care, Inc.
K760804	T-PUMP, TEMPERATURE - THERAPY PUMP	Oct 15, 1976	Substantially Equivalent	Gaymar Industries, Inc.
K760527	T-PAD	Sep 03, 1976	Substantially Equivalent	Gaymar Industries, Inc.