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Panels › Physical Medicine › Product code ILO · Class 2

Pack, Hot Or Cold, Water Circulating

Regulation 890.5720

0510(k)s in 12 months (93 all time)
4recalls in 12 months (22 all time)
4recalls that name a 510(k)
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Top companies in ILO

Company510(k)sRecalls
Breg, Inc.62
Hollister, Inc.70
DeRoyal Industries Inc06
Seabrook Medical Systems, Inc.60
Gaymar Industries, Inc.50
Burke Neutech, Inc.40
Cincinnati Sub-Zero Products Inc04
DJO, LLC04
Thermo Temp, Inc.40
Electro-Biology, Inc.30
Decided510(k)Device and applicantCode
Mar 31, 1993K923643MEDICOOL
Micromedic Systems
ILO
Jul 21, 1992K921540COOLING/HEATING THERAPY DEVICE
Tempacure Home Care
ILO
Mar 20, 1992K920581POLAR PAD (STERILE)
Breg, Inc.
ILO
Feb 3, 1992K915196INCARE HOT/ICE SYSTEM 3
Hollister, Inc.
ILO
Dec 13, 1991K913026TTU-100THERMAL THERAPY UNIT
Danninger Medical Technology, Inc.
ILO
Oct 24, 1991K914434POLAR PADS
Breg, Inc.
ILO
Oct 18, 1991K914182GOLDEN THERMAL(R)
Seabrook Medical Systems, Inc.
ILO
Oct 18, 1991K913729POLAR PUMP, MODEL 500
Breg, Inc.
ILO
Sep 11, 1991K912722HYPER-K HEAT SYSTEM
Baxter Healthcare Corp
ILO
Jul 19, 1991K911943CONCEPT MODEL 5200 THERMAL THERAPY SYSTEM
Burke, Inc.
ILO
Feb 13, 1991K910061K-MODULE II HEAT THERAPY SYSTEM
Baxter Healthcare Corp
ILO
Jan 14, 1991K904998THE BODY COOLER SYSTEM
Costa / French
ILO
Jun 21, 1990K902269ELECTRI-COOL(TM) LIQUID-CIRCULAT. THERMAL THERAPY
Seabrook Medical Systems, Inc.
ILO
Jun 21, 1990K902268PEDIA-TEMP(TM) LIQUID-CIRCULATING HYPO-HYPERTHERM.
Seabrook Medical Systems, Inc.
ILO
May 7, 1990K900356THERMOAIRE SPLINT (TM) (TAS)
Life Enhancement Technologies, LLC
ILO
Mar 26, 1990K891091TEMPTEK T-1000 THERAPEUTIC COOLING UNIT
Temptek, Inc.
ILO
Feb 15, 1990K900355MARK VII THERMOREGULATION ASSIST SYSTEM
Life Enhancement Technologies, LLC
ILO
Jul 25, 1989K891603BODY COOLER OR COOLVEST OR ALPHA BODY COOLER
Alpha Rehabilitation Products
ILO
Jun 22, 1989K893706COLD/HOT FLUID RADIATION PAD NEUTECH
Burke, Inc.
ILO
May 26, 1989K891092TEMPTEK 5010 THERMAL COOLING BLANKET
Temptek, Inc.
ILO
Apr 14, 1989K890853AQUA-PAD FOR MOIST OR DRY HEAT THERAPY
Ati
ILO
Apr 14, 1989K890852AQUA-BLANKET HYPER/HYPOHERMIA BLANKET
Ati
ILO
Apr 6, 1989K891151COOL 'N HEAT MACHINE
Kinetic Concepts, Inc.
ILO
Mar 23, 1989K891152GRAND COOLING MACHINE
Kinetic Concepts, Inc.
ILO
Nov 8, 1988K884255CONCEPT CCT-5200, THERMAL THERAPY SYSTEM
Concept, Inc.
ILO
Sep 30, 1988K883681DAS SPORT PUMP(TM)
D.A. Schulman, Inc.
ILO
Sep 23, 1988K882310DUAL-TEMP(TM) COOLING/WARMING UNIT
Seabrook Medical Systems, Inc.
ILO
Jun 26, 1987K871963HOT/ICE DISPOSABLE BLANKET
Thermo Temp, Inc.
ILO
Jun 26, 1987K871962HOT/ICE DUAL FUNCTION EQUIPMENT
Thermo Temp, Inc.
ILO
Sep 5, 1985K852495CAST-TECH CO. COOLING SYSTEM
Cast-Tech Co.
ILO
Aug 17, 1984K843146MICRO-TEMP PUMPS & MICRO-TEMP PADS
Seabrook Medical Systems, Inc.
ILO
Nov 28, 1983K833564HOT/ICE DISPOSABLE BLANKET
Thermo Temp, Inc.
ILO
Sep 26, 1983K832820MUL-T-BLANKET
Gaymar Industries, Inc.
ILO
Sep 26, 1983K832819MUL-T-PAD
Gaymar Industries, Inc.
ILO
Mar 29, 1983K830757HOT/ICE
Thermo Temp, Inc.
ILO
Jun 20, 1980K801301GOLDEN THERMAL RHINOPLASTY CAST BANDAGE
Auric, Inc.
ILO
Sep 4, 1979K791162GELSKIN
Spenco Medical Corp.
ILO
Jun 21, 1978K780452THERA-PAK
Hydro-Med Products, Inc.
ILO
Feb 24, 1977K761254BAND-AGE ICE-BANDAGE
Surgicot, Inc.
ILO
Dec 16, 1976K760910DISPOSABLE K-PADS
Gorman Rupp Industries
ILO
Dec 2, 1976K760782TECNOL PATIENT USE ICE PACK
Tecnol New Jersey Wound Care, Inc.
ILO
Oct 15, 1976K760804T-PUMP, TEMPERATURE - THERAPY PUMP
Gaymar Industries, Inc.
ILO
Sep 3, 1976K760527T-PAD
Gaymar Industries, Inc.
ILO

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