Pack, Hot Or Cold, Water Circulating

FDA product code ILO · 93 cleared devices

Class 2 Physical Medicine

Regulation: 21 CFR 890.5720
Review panel: PM
Implant: No
Life sustaining: No
Third party review: No
GMP exempt: No
Clearance span: 1976-09-03 – 2022-06-10

ILO 2022-06-10

Armory Motion

Applicant Pain Management Technologies, Inc.

K number K213097

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ILO 2009-06-10

COOLSKIN

Applicant Elbio Co., Ltd.

K number K083008

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ILO 2008-05-08

T-PUMP LOCALIZED TEMPERATURE THERAPY PUMP

Applicant Gaymar Industries, Inc.

K number K073675

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ILO 2007-09-07

JUNIPER CLN1 DERMAL COOLING DEVICE

Applicant Juniper Medical, Inc.

K number K072152

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ILO 2007-03-29

MODIFICATION TO POLAR CARE 500

Applicant Breg, Inc.

K number K070402

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ILO 2004-05-07

IVC SYSTEM

Applicant Mark H. Friedman

K number K040317

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ILO 1997-11-03

INCARE HOT/ICE SYSTEM FOOT/ANKLE BLANKET

Applicant Hollister, Inc.

K number K973023

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ILO 1997-09-10

HTP-1500 LOCALIZED HEAT THERAPY PUMP

Applicant Adroit Medical Systems, Inc.

K number K970197

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ILO 1997-08-29

ARTROTHERM CRYOTHERAPY AND THERNOTHERAPY

Applicant Ormed GmbH

K number K964799

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ILO 1997-08-29

ARTOCOOL-S WATER CIRCULATING COLD PACK

Applicant Ormed GmbH

K number K964354

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ILO 1997-05-09

BLEDSOE COLD CONTROL

Applicant Med Technology, Inc.

K number K964710

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ILO 1997-04-15

MODEL 1100 COLD THERAPY DEVICE

Applicant Smith & Nephew, Inc.

K number K970533

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ILO 1997-01-10

STERILE SOFT-TEMP

Applicant Adroit Medical Systems, Inc.

K number K962983

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ILO 1996-12-31

INCARE HOT/ICE SYSTEM SHOULDER BLANKET

Applicant Hollister, Inc.

K number K964057

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ILO 1996-12-31

INCARE HOT/ICE SYSTEM BLANKETS (VARIOUS SIZES AND SHAPES)

Applicant Hollister, Inc.

K number K964006

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ILO 1996-12-04

POLAR CARE 300

Applicant Breg, Inc.

K number K963596

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ILO 1996-11-27

INCARE HOT/ICE LITE MACHINE

Applicant Hollister, Inc.

K number K962537

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ILO 1996-10-31

THERAPY CONCEPTS WATER CIRCULATING TREATMENT SYSTEM

Applicant Therapy Concepts, Inc.

K number K961621

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ILO 1996-10-28

BIO COMPRESSION COLD FLO, SINGLE CHAMBER INTERMITTENT AND MULTI-CHAMBER SEQUENTIAL MODELS

Applicant Bio Compression Systems, Inc.

K number K961425

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ILO 1996-09-27

EBI THERMAL THERAPY SYSTEM

Applicant Electro-Biology, Inc.

K number K963261

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ILO 1996-08-09

POLAR CARE (MODEL 500/50000)

Applicant Breg, Inc.

K number K961855

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ILO 1996-06-10

CRYTRON SYSTEM

Applicant Mark H. Friedman

K number K955529

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ILO 1996-04-10

SPORTS CONTRAST THERAPY SYSTEM ST 7000

Applicant Burke Neutech, Inc.

K number K955326

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ILO 1996-03-08

MODEL 1100 COLD THERAPY DEVICE

Applicant Smith and Nephew Donjoy, Inc.

K number K955057

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ILO 1996-03-06

MEDICOOL (MODIFICATON)

Applicant Microclimate Systems, Inc.

K number K954095

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ILO 1995-10-05

THERMOTEK H-300

Applicant Thermotek, Inc.

K number K945853

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ILO 1995-10-04

EBICE

Applicant Electro-Biology, Inc.

K number K953532

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ILO 1995-08-18

THERMOCOOL SYSTEM

Applicant Zimmer, Inc.

K number K950395

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ILO 1995-07-06

T-350 THERAPEUTIC COOLING MACHINE

Applicant Thermotek, Inc.

K number K950711

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ILO 1995-06-19

T-300 COOLER

Applicant Temptek, Inc.

K number K945468

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ILO 1995-06-07

CONTRAST 7000 THERAPY SYSTEM

Applicant Burke Neutech, Inc.

K number K943497

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ILO 1995-04-28

BABYTHERM 8000 WB

Applicant Drager, Inc.

K number K945467

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ILO 1995-04-18

HPRH HOSPITAL PATIENT RADIANT HEATER

Applicant Marley Electric Heating Co.

K number K934262

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ILO 1995-03-07

DELTA THERM COLD THERAPY SYSTEM

Applicant Deltatherm

K number K945399

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ILO 1995-02-09

EBICE

Applicant Electro-Biology, Inc.

K number K945067

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ILO 1995-02-09

COOL/HEAT THERAPY APPLICATOR

Applicant Medical Science Technology, Inc.

K number K944447

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ILO 1995-02-09

TOTALLY COOL(TM) TC-1

Applicant Electro Science Technologies, Inc.

K number K943844

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ILO 1995-02-09

TOTALLY COOL(TM) TC-2

Applicant Electro Science Technologies, Inc.

K number K942882

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ILO 1995-01-30

INCARE HOT/ICE COLD THERAPY COOLER

Applicant Hollister, Inc.

K number K944971

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ILO 1994-08-29

DR KOOL

Applicant Toronto Medical Corp.

K number K935841

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ILO 1994-07-12

THERA COOL HOME UNIT/COOLPAC(AMBU/RESERVIOR UNITS)

Applicant Innovation Sports, Inc.

K number K940858

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ILO 1994-07-12

ORTHO TECH CRYOLOGIC SYSTEM

Applicant Orthopedic Technology, Inc.

K number K940429

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ILO 1994-07-12

ISOCOMFORTER

Applicant Isocomforter, Inc.

K number K936143

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ILO 1994-05-27

TS1000 PORTABLE DISPOSABLE COLD THERAPY SYSTEM

Applicant Burke Neutech, Inc.

K number K940160

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ILO 1994-05-25

HYDROT

Applicant Sanker Intl., Inc.

K number K930918

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ILO 1994-02-22

COOL-AID

Applicant Seabrook Medical Systems, Inc.

K number K931203

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ILO 1994-02-02

HOT/ICE SYSTEM STERILE CONFORMABLE/DISP. BLANKETS

Applicant Hollister, Inc.

K number K931843

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ILO 1993-11-01

SUR FLO THERMAL THERAPY PADS

Applicant Buckman Co., Inc.

K number K930634

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ILO 1993-05-26

LSI6000 THERMAL THERAPY SYSTEM

Applicant Burke Neutech, Inc.

K number K926151

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ILO 1993-04-14

AUTOCHILL ACCESSORY KIT

Applicant Aircast, Inc.

K number K925677

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ILO 1993-03-31

MEDICOOL

Applicant Micromedic Systems

K number K923643

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ILO 1992-07-21

COOLING/HEATING THERAPY DEVICE

Applicant Tempacure Home Care

K number K921540

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ILO 1992-03-20

POLAR PAD (STERILE)

Applicant Breg, Inc.

K number K920581

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ILO 1992-02-03

INCARE HOT/ICE SYSTEM 3

Applicant Hollister, Inc.

K number K915196

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ILO 1991-12-13

TTU-100THERMAL THERAPY UNIT

Applicant Danninger Medical Technology, Inc.

K number K913026

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ILO 1991-10-24

POLAR PADS

Applicant Breg, Inc.

K number K914434

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ILO 1991-10-18

GOLDEN THERMAL(R)

Applicant Seabrook Medical Systems, Inc.

K number K914182

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ILO 1991-10-18

POLAR PUMP, MODEL 500

Applicant Breg, Inc.

K number K913729

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ILO 1991-09-11

HYPER-K HEAT SYSTEM

Applicant Baxter Healthcare Corp

K number K912722

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ILO 1991-07-19

CONCEPT MODEL 5200 THERMAL THERAPY SYSTEM

Applicant Burke, Inc.

K number K911943

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ILO 1991-02-13

K-MODULE II HEAT THERAPY SYSTEM

Applicant Baxter Healthcare Corp

K number K910061

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ILO 1991-01-14

THE BODY COOLER SYSTEM

Applicant Costa / French

K number K904998

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ILO 1990-06-21

ELECTRI-COOL(TM) LIQUID-CIRCULAT. THERMAL THERAPY

Applicant Seabrook Medical Systems, Inc.

K number K902269

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ILO 1990-06-21

PEDIA-TEMP(TM) LIQUID-CIRCULATING HYPO-HYPERTHERM.

Applicant Seabrook Medical Systems, Inc.

K number K902268

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ILO 1990-05-07

THERMOAIRE SPLINT (TM) (TAS)

Applicant Life Enhancement Technologies, LLC

K number K900356

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ILO 1990-03-26

TEMPTEK T-1000 THERAPEUTIC COOLING UNIT

Applicant Temptek, Inc.

K number K891091

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ILO 1990-02-15

MARK VII THERMOREGULATION ASSIST SYSTEM

Applicant Life Enhancement Technologies, LLC

K number K900355

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ILO 1989-07-25

BODY COOLER OR COOLVEST OR ALPHA BODY COOLER

Applicant Alpha Rehabilitation Products

K number K891603

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ILO 1989-06-22

COLD/HOT FLUID RADIATION PAD NEUTECH

Applicant Burke, Inc.

K number K893706

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ILO 1989-05-26

TEMPTEK 5010 THERMAL COOLING BLANKET

Applicant Temptek, Inc.

K number K891092

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ILO 1989-04-14

AQUA-PAD FOR MOIST OR DRY HEAT THERAPY

Applicant Ati

K number K890853

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ILO 1989-04-14

AQUA-BLANKET HYPER/HYPOHERMIA BLANKET

Applicant Ati

K number K890852

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ILO 1989-04-06

COOL 'N HEAT MACHINE

Applicant Kinetic Concepts, Inc.

K number K891151

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ILO 1989-03-23

GRAND COOLING MACHINE

Applicant Kinetic Concepts, Inc.

K number K891152

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ILO 1988-11-08

CONCEPT CCT-5200, THERMAL THERAPY SYSTEM

Applicant Concept, Inc.

K number K884255

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ILO 1988-09-30

DAS SPORT PUMP(TM)

Applicant D.A. Schulman, Inc.

K number K883681

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ILO 1988-09-23

DUAL-TEMP(TM) COOLING/WARMING UNIT

Applicant Seabrook Medical Systems, Inc.

K number K882310

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ILO 1987-06-26

HOT/ICE DISPOSABLE BLANKET

Applicant Thermo Temp, Inc.

K number K871963

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ILO 1987-06-26

HOT/ICE DUAL FUNCTION EQUIPMENT

Applicant Thermo Temp, Inc.

K number K871962

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ILO 1985-09-05

CAST-TECH CO. COOLING SYSTEM

Applicant Cast-Tech Co.

K number K852495

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ILO 1984-08-17

MICRO-TEMP PUMPS & MICRO-TEMP PADS

Applicant Seabrook Medical Systems, Inc.

K number K843146

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ILO 1983-11-28

HOT/ICE DISPOSABLE BLANKET

Applicant Thermo Temp, Inc.

K number K833564

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ILO 1983-09-26

MUL-T-BLANKET

Applicant Gaymar Industries, Inc.

K number K832820

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ILO 1983-09-26

MUL-T-PAD

Applicant Gaymar Industries, Inc.

K number K832819

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ILO 1983-03-29

HOT/ICE

Applicant Thermo Temp, Inc.

K number K830757

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ILO 1980-06-20

GOLDEN THERMAL RHINOPLASTY CAST BANDAGE

Applicant Auric, Inc.

K number K801301

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ILO 1979-09-04

GELSKIN

Applicant Spenco Medical Corp.

K number K791162

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ILO 1978-06-21

THERA-PAK

Applicant Hydro-Med Products, Inc.

K number K780452

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ILO 1977-02-24

BAND-AGE ICE-BANDAGE

Applicant Surgicot, Inc.

K number K761254

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ILO 1976-12-16

DISPOSABLE K-PADS

Applicant Gorman Rupp Industries

K number K760910

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ILO 1976-12-02

TECNOL PATIENT USE ICE PACK

Applicant Tecnol New Jersey Wound Care, Inc.

K number K760782

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ILO 1976-10-15

T-PUMP, TEMPERATURE - THERAPY PUMP

Applicant Gaymar Industries, Inc.

K number K760804

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ILO 1976-09-03

T-PAD

Applicant Gaymar Industries, Inc.

K number K760527

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