Anesthesiology
Review Panel
- CardiovascularReview Panel
- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
- HematologyReview Panel
- ImmunologyReview Panel
- MicrobiologyReview Panel
- NeurologyReview Panel
- Obstetrical and GynecologicalReview Panel
- OphthalmicReview Panel
- OrthopedicReview Panel
- PathologyReview Panel
- Physical MedicineReview Panel
- MiscellaneousMiscellaneous
- Subpart B—Physical Medicine Diagnostic DevicesCFR Sub-Part
- Subpart D—Physical Medicine Prosthetic DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- Subpart F—Neurological Therapeutic DevicesCFR Sub-Part
- Subpart F—Physical Medicine Therapeutic DevicesCFR Sub-Part
- MOCCushion, Flotation, Therapeutic2Product Code
- IMGStimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat2Product Code
- IMIUltrasonic Diathermy For Use In Applying Therapeutic Deep Heat2Product Code
- IMJDiathermy, Shortwave, For Use In Applying Therapeutic Deep Heat2Product Code
- QOLElectroencephalography (Eeg)-Driven Upper Extremity Powered Exerciser2Product Code
- QRAVirtual Reality Behavioral Therapy Device For Pain Relief2Product Code
- BXBExerciser, Powered1Product Code
- EGJDevice, Iontophoresis, Other Uses2Product Code
- HPHDiathermy, Microwave, For Use Other Than Applying Therapeutic Deep Heat3Product Code
- IKWUtensil, Homemaking1Product Code
- IKXAid, Transfer1Product Code
- IKZBed, Patient Rotation, Powered2Product Code
- ILCUtensil, Eating1Product Code
- ILDAdaptor, Dressing1Product Code
- ILJBath, Hydro-Massage2Product Code
- ILKTransport, Patient, Powered2Product Code
- ILMBath, Sitz, Powered2Product Code
- ILOPack, Hot Or Cold, Water Circulating2Product Code
- K213097Armory Motion2Cleared 510(K)
- K083008COOLSKIN2Cleared 510(K)
- K073675T-PUMP LOCALIZED TEMPERATURE THERAPY PUMP2Cleared 510(K)
- K072152JUNIPER CLN1 DERMAL COOLING DEVICE2Cleared 510(K)
- K070402MODIFICATION TO POLAR CARE 5002Cleared 510(K)
- K040317IVC SYSTEM2Cleared 510(K)
- K973023INCARE HOT/ICE SYSTEM FOOT/ANKLE BLANKET2Cleared 510(K)
- K970197HTP-1500 LOCALIZED HEAT THERAPY PUMP2Cleared 510(K)
- K964799ARTROTHERM CRYOTHERAPY AND THERNOTHERAPY2Cleared 510(K)
- K964354ARTOCOOL-S WATER CIRCULATING COLD PACK2Cleared 510(K)
- K964710BLEDSOE COLD CONTROL2Cleared 510(K)
- K970533MODEL 1100 COLD THERAPY DEVICE2Cleared 510(K)
- K962983STERILE SOFT-TEMP2Cleared 510(K)
- K964057INCARE HOT/ICE SYSTEM SHOULDER BLANKET2Cleared 510(K)
- K964006INCARE HOT/ICE SYSTEM BLANKETS (VARIOUS SIZES AND SHAPES)2Cleared 510(K)
- K963596POLAR CARE 3002Cleared 510(K)
- K962537INCARE HOT/ICE LITE MACHINE2Cleared 510(K)
- K961621THERAPY CONCEPTS WATER CIRCULATING TREATMENT SYSTEM2Cleared 510(K)
- K961425BIO COMPRESSION COLD FLO, SINGLE CHAMBER INTERMITTENT AND MULTI-CHAMBER SEQUENTIAL MODELS2Cleared 510(K)
- K963261EBI THERMAL THERAPY SYSTEM2Cleared 510(K)
- K961855POLAR CARE (MODEL 500/50000)2Cleared 510(K)
- K955529CRYTRON SYSTEM2Cleared 510(K)
- K955326SPORTS CONTRAST THERAPY SYSTEM ST 70002Cleared 510(K)
- K955057MODEL 1100 COLD THERAPY DEVICE2Cleared 510(K)
- K954095MEDICOOL (MODIFICATON)2Cleared 510(K)
- K945853THERMOTEK H-3002Cleared 510(K)
- K953532EBICE2Cleared 510(K)
- K950395THERMOCOOL SYSTEM2Cleared 510(K)
- K950711T-350 THERAPEUTIC COOLING MACHINE2Cleared 510(K)
- K945468T-300 COOLER2Cleared 510(K)
- K943497CONTRAST 7000 THERAPY SYSTEM2Cleared 510(K)
- K945467BABYTHERM 8000 WB2Cleared 510(K)
- K934262HPRH HOSPITAL PATIENT RADIANT HEATER2Cleared 510(K)
- K945399DELTA THERM COLD THERAPY SYSTEM2Cleared 510(K)
- K945067EBICE2Cleared 510(K)
- K944447COOL/HEAT THERAPY APPLICATOR2Cleared 510(K)
- K942882TOTALLY COOL(TM) TC-22Cleared 510(K)
- K943844TOTALLY COOL(TM) TC-12Cleared 510(K)
- K944971INCARE HOT/ICE COLD THERAPY COOLER2Cleared 510(K)
- K935841DR KOOL2Cleared 510(K)
- K940858THERA COOL HOME UNIT/COOLPAC(AMBU/RESERVIOR UNITS)2Cleared 510(K)
- K940429ORTHO TECH CRYOLOGIC SYSTEM2Cleared 510(K)
- K936143ISOCOMFORTER2Cleared 510(K)
- K940160TS1000 PORTABLE DISPOSABLE COLD THERAPY SYSTEM2Cleared 510(K)
- K930918HYDROT2Cleared 510(K)
- K931203COOL-AID2Cleared 510(K)
- K931843HOT/ICE SYSTEM STERILE CONFORMABLE/DISP. BLANKETS2Cleared 510(K)
- K930634SUR FLO THERMAL THERAPY PADS2Cleared 510(K)
- K926151LSI6000 THERMAL THERAPY SYSTEM2Cleared 510(K)
- K925677AUTOCHILL ACCESSORY KIT2Cleared 510(K)
- K923643MEDICOOL2Cleared 510(K)
- K921540COOLING/HEATING THERAPY DEVICE2Cleared 510(K)
- K920581POLAR PAD (STERILE)2Cleared 510(K)
- K915196INCARE HOT/ICE SYSTEM 32Cleared 510(K)
- K913026TTU-100THERMAL THERAPY UNIT2Cleared 510(K)
- K914434POLAR PADS2Cleared 510(K)
- K914182GOLDEN THERMAL(R)2Cleared 510(K)
- K913729POLAR PUMP, MODEL 5002Cleared 510(K)
- K912722HYPER-K HEAT SYSTEM2Cleared 510(K)
- K911943CONCEPT MODEL 5200 THERMAL THERAPY SYSTEM2Cleared 510(K)
- K910061K-MODULE II HEAT THERAPY SYSTEM2Cleared 510(K)
- K904998THE BODY COOLER SYSTEM2Cleared 510(K)
- K902268PEDIA-TEMP(TM) LIQUID-CIRCULATING HYPO-HYPERTHERM.2Cleared 510(K)
- K902269ELECTRI-COOL(TM) LIQUID-CIRCULAT. THERMAL THERAPY2Cleared 510(K)
- K900356THERMOAIRE SPLINT (TM) (TAS)2Cleared 510(K)
- K891091TEMPTEK T-1000 THERAPEUTIC COOLING UNIT2Cleared 510(K)
- K900355MARK VII THERMOREGULATION ASSIST SYSTEM2Cleared 510(K)
- K891603BODY COOLER OR COOLVEST OR ALPHA BODY COOLER2Cleared 510(K)
- K893706COLD/HOT FLUID RADIATION PAD NEUTECH2Cleared 510(K)
- K891092TEMPTEK 5010 THERMAL COOLING BLANKET2Cleared 510(K)
- K890852AQUA-BLANKET HYPER/HYPOHERMIA BLANKET2Cleared 510(K)
- K890853AQUA-PAD FOR MOIST OR DRY HEAT THERAPY2Cleared 510(K)
- K891151COOL 'N HEAT MACHINE2Cleared 510(K)
- K891152GRAND COOLING MACHINE2Cleared 510(K)
- K884255CONCEPT CCT-5200, THERMAL THERAPY SYSTEM2Cleared 510(K)
- K883681DAS SPORT PUMP(TM)2Cleared 510(K)
- K882310DUAL-TEMP(TM) COOLING/WARMING UNIT2Cleared 510(K)
- K871962HOT/ICE DUAL FUNCTION EQUIPMENT2Cleared 510(K)
- K871963HOT/ICE DISPOSABLE BLANKET2Cleared 510(K)
- K852495CAST-TECH CO. COOLING SYSTEM2Cleared 510(K)
- K843146MICRO-TEMP PUMPS & MICRO-TEMP PADS2Cleared 510(K)
- K833564HOT/ICE DISPOSABLE BLANKET2Cleared 510(K)
- K832819MUL-T-PAD2Cleared 510(K)
- K832820MUL-T-BLANKET2Cleared 510(K)
- K830757HOT/ICE2Cleared 510(K)
- K801301GOLDEN THERMAL RHINOPLASTY CAST BANDAGE2Cleared 510(K)
- K791162GELSKIN2Cleared 510(K)
- K780452THERA-PAK2Cleared 510(K)
- K761254BAND-AGE ICE-BANDAGE2Cleared 510(K)
- K760910DISPOSABLE K-PADS2Cleared 510(K)
- K760782TECNOL PATIENT USE ICE PACK2Cleared 510(K)
- K760804T-PUMP, TEMPERATURE - THERAPY PUMP2Cleared 510(K)
- K760527T-PAD2Cleared 510(K)
- ILSAdaptor, Hygiene1Product Code
- ILTAdaptor, Recreational1Product Code
- ILWAdaptor, Grooming1Product Code
- ILXDiathermy, Shortwave, For Use Other Than Applying Therapeutic Deep Heat2Product Code
- ILYLamp, Infrared, Therapeutic Heating2Product Code
- ILZAccessories, Traction1Product Code
- IMAPack, Heat, Moist1Product Code
- IMBCabinet, Moist Steam2Product Code
- IMCBath, Paraffin2Product Code
- IMDPack, Hot Or Cold, Disposable1Product Code
- IMEPack, Hot Or Cold, Reusable1Product Code
- IMFUnit, Chilling1Product Code
- INXBed, Air Fluidized2Product Code
- INYBed, Patient Rotation, Manual1Product Code
- IOADiathermy, Microwave, For Use In Applying Therapeutic Deep Heat2Product Code
- IOBLamp, Infrared, Non Heating2Product Code
- IODComponents, Exercise1Product Code
- IOEBars, Parallel, Exercise1Product Code
- IOGTreadmill, Mechanical1Product Code
- IOLTreadmill, Powered1Product Code
- IONExerciser, Non-Measuring1Product Code
- IOQBed, Flotation Therapy, Powered2Product Code
- IPFStimulator, Muscle, Powered2Product Code
- IRNDevice, Warning, Overload, External Limb, Powered2Product Code
- IROVibrator, Therapeutic1Product Code
- IRPMassager, Powered Inflatable Tube2Product Code
- IRQUnit, Heating, Powered1Product Code
- IRRBars, Parallel, Powered1Product Code
- IRSHead Halter, Traction1Product Code
- IRTPad, Heating, Powered2Product Code
- ISAMassager, Therapeutic, Electric1Product Code
- ISDExerciser, Measuring2Product Code
- ITHEquipment, Traction, Powered2Product Code
- JFAExerciser, Finger, Powered1Product Code
- JFBTable, Physical Therapy, Multi Function2Product Code
- KNLBoard, Scooter, Prone1Product Code
- KNMDevice, Pressure Applying1Product Code
- KTBDevice, Iontophoresis, Specific Uses2Product Code
- KTCBath, Sitz, Nonpowered1Product Code
- LBGDevice, Fluidized Therapy, Dry Heat2Product Code
- LSBUnit, Fluidotherapy2Product Code
- LXFDiathermy, Ultrasonic, For Use Other Than Applying Therapeutic Deep Heat3Product Code
- LXJInteractive Rehabilitation Exercise Devices2Product Code
- LYGMassager, Therapeutic, Manual1Product Code
- MPOInfant Heel Warmer (Chemical Heat Pack)1Product Code
- NGXStimulator, Muscle, Powered, For Muscle Conditioning2Product Code
- NHNPowered Light Based Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy2Product Code
- NYYStimulator, Muscle, Powered, With Limited Output, For Rehabilitation2Product Code
- NYZStimulator, Muscle, Powered, With Limited Output, For Muscle Conditioning2Product Code
- OMWAdhesive Backed Thermal Skin Patches1Product Code
- OSDMassager, Therapeutic, To Internally Massage Trigger Points In The Pelvic Floor Musculature2Product Code
- PCDPowered Stairway Chair Lift2Product Code
- PFWStationary Ultrasonic Diathermy Device For Use In Applying Therapeutic Deep Heat2Product Code
- PHWCold Pack And Vibrating Massager1Product Code
- PKSExerciser, Non-Measuring For Stroke Rehabilitation1Product Code
- PQYNonthermal Shortwave Therapy Device Indicated For Over The Counter Use For The Treatment Of Pain2Product Code
- QKCInteractive Rehabilitation Exercise Device, Prescription Use2Product Code
- QKDMassager, Therapeutic, To Internally Massage Trigger Points In The Pelvic Floor Musculature, Prescription Use2Product Code
- QTCAdult Portable Bed Rails For Medical Purposes1Product Code
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
CONCEPT MODEL 5200 THERMAL THERAPY SYSTEM
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K911943
- 510(k) Type
- Traditional
- Applicant
- BURKE, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 7/19/1991
- Days to Decision
- 79 days
- Submission Type
- Statement