Atlas FDA

ILO

93 FDA 510(k) clearances · Product code

92 daysmedian time to decision
272 days90th percentile
93clearances measured

FDA profile

Official device name
Pack, Hot Or Cold, Water Circulating
Device class
Class II (moderate risk)
Regulation
21 CFR 890.5720
Medical specialty
Physical Medicine
Adverse events (MAUDE)
2015: 60 · 2016: 44 · 2017: 43 · 2018: 40 · 2019: 29 · 2021: 14
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
Armory Motion (K213097)Pain Management Technologies, Inc.2022-06-10
COOLSKIN (K083008)Elbio Co., Ltd.2009-06-10
T-PUMP LOCALIZED TEMPERATURE THERAPY PUMP (K073675)Gaymar Industries, Inc.2008-05-08
JUNIPER CLN1 DERMAL COOLING DEVICE (K072152)Juniper Medical, Inc.2007-09-07
MODIFICATION TO POLAR CARE 500 (K070402)Breg, Inc.2007-03-29
IVC SYSTEM (K040317)Mark H. Friedman2004-05-07
INCARE HOT/ICE SYSTEM FOOT/ANKLE BLANKET (K973023)Hollister, Inc.1997-11-03
HTP-1500 LOCALIZED HEAT THERAPY PUMP (K970197)Adroit Medical Systems, Inc.1997-09-10
ARTROTHERM CRYOTHERAPY AND THERNOTHERAPY (K964799)Ormed GmbH1997-08-29
ARTOCOOL-S WATER CIRCULATING COLD PACK (K964354)Ormed GmbH1997-08-29
BLEDSOE COLD CONTROL (K964710)Med Technology, Inc.1997-05-09
MODEL 1100 COLD THERAPY DEVICE (K970533)Smith & Nephew, Inc.1997-04-15
STERILE SOFT-TEMP (K962983)Adroit Medical Systems, Inc.1997-01-10
INCARE HOT/ICE SYSTEM BLANKETS (VARIOUS SIZES AND SHAPES) (K964006)Hollister, Inc.1996-12-31
INCARE HOT/ICE SYSTEM SHOULDER BLANKET (K964057)Hollister, Inc.1996-12-31
POLAR CARE 300 (K963596)Breg, Inc.1996-12-04
INCARE HOT/ICE LITE MACHINE (K962537)Hollister, Inc.1996-11-27
THERAPY CONCEPTS WATER CIRCULATING TREATMENT SYSTEM (K961621)Therapy Concepts, Inc.1996-10-31
BIO COMPRESSION COLD FLO, SINGLE CHAMBER INTERMITTENT AND MULTI-CHAMBER SEQUENTIAL MODELS (K961425)Bio Compression Systems, Inc.1996-10-28
EBI THERMAL THERAPY SYSTEM (K963261)Electro-Biology, Inc.1996-09-27
POLAR CARE (MODEL 500/50000) (K961855)Breg, Inc.1996-08-09
CRYTRON SYSTEM (K955529)Mark H. Friedman1996-06-10
SPORTS CONTRAST THERAPY SYSTEM ST 7000 (K955326)Burke Neutech, Inc.1996-04-10
MODEL 1100 COLD THERAPY DEVICE (K955057)Smith and Nephew Donjoy, Inc.1996-03-08
MEDICOOL (MODIFICATON) (K954095)Microclimate Systems, Inc.1996-03-06
THERMOTEK H-300 (K945853)Thermotek, Inc.1995-10-05
EBICE (K953532)Electro-Biology, Inc.1995-10-04
THERMOCOOL SYSTEM (K950395)Zimmer, Inc.1995-08-18
T-350 THERAPEUTIC COOLING MACHINE (K950711)Thermotek, Inc.1995-07-06
T-300 COOLER (K945468)Temptek, Inc.1995-06-19
CONTRAST 7000 THERAPY SYSTEM (K943497)Burke Neutech, Inc.1995-06-07
BABYTHERM 8000 WB (K945467)Drager, Inc.1995-04-28
HPRH HOSPITAL PATIENT RADIANT HEATER (K934262)Marley Electric Heating Co.1995-04-18
DELTA THERM COLD THERAPY SYSTEM (K945399)Deltatherm1995-03-07
COOL/HEAT THERAPY APPLICATOR (K944447)Medical Science Technology, Inc.1995-02-09
TOTALLY COOL(TM) TC-1 (K943844)Electro Science Technologies, Inc.1995-02-09
EBICE (K945067)Electro-Biology, Inc.1995-02-09
TOTALLY COOL(TM) TC-2 (K942882)Electro Science Technologies, Inc.1995-02-09
INCARE HOT/ICE COLD THERAPY COOLER (K944971)Hollister, Inc.1995-01-30
DR KOOL (K935841)Toronto Medical Corp.1994-08-29
ISOCOMFORTER (K936143)Isocomforter, Inc.1994-07-12
THERA COOL HOME UNIT/COOLPAC(AMBU/RESERVIOR UNITS) (K940858)Innovation Sports, Inc.1994-07-12
ORTHO TECH CRYOLOGIC SYSTEM (K940429)Orthopedic Technology, Inc.1994-07-12
TS1000 PORTABLE DISPOSABLE COLD THERAPY SYSTEM (K940160)Burke Neutech, Inc.1994-05-27
HYDROT (K930918)Sanker Intl., Inc.1994-05-25
COOL-AID (K931203)Seabrook Medical Systems, Inc.1994-02-22
HOT/ICE SYSTEM STERILE CONFORMABLE/DISP. BLANKETS (K931843)Hollister, Inc.1994-02-02
SUR FLO THERMAL THERAPY PADS (K930634)Buckman Co., Inc.1993-11-01
LSI6000 THERMAL THERAPY SYSTEM (K926151)Burke Neutech, Inc.1993-05-26
AUTOCHILL ACCESSORY KIT (K925677)Aircast, Inc.1993-04-14
MEDICOOL (K923643)Micromedic Systems1993-03-31
COOLING/HEATING THERAPY DEVICE (K921540)Tempacure Home Care1992-07-21
POLAR PAD (STERILE) (K920581)Breg, Inc.1992-03-20
INCARE HOT/ICE SYSTEM 3 (K915196)Hollister, Inc.1992-02-03
TTU-100THERMAL THERAPY UNIT (K913026)Danninger Medical Technology, Inc.1991-12-13
POLAR PADS (K914434)Breg, Inc.1991-10-24
GOLDEN THERMAL(R) (K914182)Seabrook Medical Systems, Inc.1991-10-18
POLAR PUMP, MODEL 500 (K913729)Breg, Inc.1991-10-18
HYPER-K HEAT SYSTEM (K912722)Baxter Healthcare Corp1991-09-11
CONCEPT MODEL 5200 THERMAL THERAPY SYSTEM (K911943)Burke, Inc.1991-07-19
K-MODULE II HEAT THERAPY SYSTEM (K910061)Baxter Healthcare Corp1991-02-13
THE BODY COOLER SYSTEM (K904998)Costa / French1991-01-14
PEDIA-TEMP(TM) LIQUID-CIRCULATING HYPO-HYPERTHERM. (K902268)Seabrook Medical Systems, Inc.1990-06-21
ELECTRI-COOL(TM) LIQUID-CIRCULAT. THERMAL THERAPY (K902269)Seabrook Medical Systems, Inc.1990-06-21
THERMOAIRE SPLINT (TM) (TAS) (K900356)Life Enhancement Technologies, LLC1990-05-07
TEMPTEK T-1000 THERAPEUTIC COOLING UNIT (K891091)Temptek, Inc.1990-03-26
MARK VII THERMOREGULATION ASSIST SYSTEM (K900355)Life Enhancement Technologies, LLC1990-02-15
BODY COOLER OR COOLVEST OR ALPHA BODY COOLER (K891603)Alpha Rehabilitation Products1989-07-25
COLD/HOT FLUID RADIATION PAD NEUTECH (K893706)Burke, Inc.1989-06-22
TEMPTEK 5010 THERMAL COOLING BLANKET (K891092)Temptek, Inc.1989-05-26
AQUA-BLANKET HYPER/HYPOHERMIA BLANKET (K890852)Ati1989-04-14
AQUA-PAD FOR MOIST OR DRY HEAT THERAPY (K890853)Ati1989-04-14
COOL 'N HEAT MACHINE (K891151)Kinetic Concepts, Inc.1989-04-06
GRAND COOLING MACHINE (K891152)Kinetic Concepts, Inc.1989-03-23
CONCEPT CCT-5200, THERMAL THERAPY SYSTEM (K884255)Concept, Inc.1988-11-08
DAS SPORT PUMP(TM) (K883681)D.A. Schulman, Inc.1988-09-30
DUAL-TEMP(TM) COOLING/WARMING UNIT (K882310)Seabrook Medical Systems, Inc.1988-09-23
HOT/ICE DUAL FUNCTION EQUIPMENT (K871962)Thermo Temp, Inc.1987-06-26
HOT/ICE DISPOSABLE BLANKET (K871963)Thermo Temp, Inc.1987-06-26
CAST-TECH CO. COOLING SYSTEM (K852495)Cast-Tech Co.1985-09-05
MICRO-TEMP PUMPS & MICRO-TEMP PADS (K843146)Seabrook Medical Systems, Inc.1984-08-17
HOT/ICE DISPOSABLE BLANKET (K833564)Thermo Temp, Inc.1983-11-28
MUL-T-PAD (K832819)Gaymar Industries, Inc.1983-09-26
MUL-T-BLANKET (K832820)Gaymar Industries, Inc.1983-09-26
HOT/ICE (K830757)Thermo Temp, Inc.1983-03-29
GOLDEN THERMAL RHINOPLASTY CAST BANDAGE (K801301)Auric, Inc.1980-06-20
GELSKIN (K791162)Spenco Medical Corp.1979-09-04
THERA-PAK (K780452)Hydro-Med Products, Inc.1978-06-21
BAND-AGE ICE-BANDAGE (K761254)Surgicot, Inc.1977-02-24
DISPOSABLE K-PADS (K760910)Gorman Rupp Industries1976-12-16
TECNOL PATIENT USE ICE PACK (K760782)Tecnol New Jersey Wound Care, Inc.1976-12-02
T-PUMP, TEMPERATURE - THERAPY PUMP (K760804)Gaymar Industries, Inc.1976-10-15
T-PAD (K760527)Gaymar Industries, Inc.1976-09-03

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Every clearance here is in the API, with alerts when new ones post.