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
- 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
- K221653InfaTherm Disposable Infant Warming Mattress1Cleared 510(K)
- K163295Infant Transport Mattress Warmer with Disc1Cleared 510(K)
- K112547NEO NEST1Cleared 510(K)
- K082087EYEFEEL OPHTHALMIC WARMER1Cleared 510(K)
- K071710BENGAY (R) HEAT THERAPY, PAIN RELIEVING PATCHES/PADS (VARIOUS)1Cleared 510(K)
- K021843EYEFEEL OPHTHALMIC WARMER1Cleared 510(K)
- K982652ALLEGIANCE PORTA-WARM MATTRESS1Cleared 510(K)
- K980509DEROYAL INDUSTRIES, INC. INFANT TRANSPORT MATTRESS1Cleared 510(K)
- K974190CP&S INSTANT COLD PACK LIMB KIT TRANSPORTER1Cleared 510(K)
- K973770ALLEGIANCE KWIK HEAT WARM PERINEAL PACK1Cleared 510(K)
- K970399KWIK KOLD PERI COLD PACK (CATALOG NUMBER TBD)1Cleared 510(K)
- K963689RECOVER ADULT VEIN WARMER1Cleared 510(K)
- K963768INSTANT HOT PACKS1Cleared 510(K)
- K963666INSTANT COLD PACK1Cleared 510(K)
- K963220TEMPRA COLD PACK, REORDER NO. TC1501Cleared 510(K)
- K961176OMNI COLD GEL PACKS1Cleared 510(K)
- K955788IMNI HOT PACKS1Cleared 510(K)
- K951033ANDELA DYNAMIC COOLING DEVICE1Cleared 510(K)
- K960624CERTI COOL INSTANT COLD COMPRESS1Cleared 510(K)
- K954877OMNI COLD GEL PACKS1Cleared 510(K)
- K953442RESTORE, THERMACELLS (HOT PACK I)1Cleared 510(K)
- K953542COLDGEL1Cleared 510(K)
- K953541INSTANT COLDGEL1Cleared 510(K)
- K950680INFANT HEEL WARMER1Cleared 510(K)
- K951383TEMPRA HEAT PACK1Cleared 510(K)
- K941245POLY-MEDICS HEAT PACK1Cleared 510(K)
- K936084OMNI WARM GEL PACKS1Cleared 510(K)
- K940336CERTI HEAT INSTANT HEAT COMPRESS1Cleared 510(K)
- K935569INSTANT HOT OR COLD DISPOSABLE PACK1Cleared 510(K)
- K934631TRANSWARMER1Cleared 510(K)
- K934673KACEY DISPOSABLE INFANT HEEL WARMER1Cleared 510(K)
- K920760PERI-K PAD COLD PACK1Cleared 510(K)
- K926590ANAGO DISPOSABLE INSTANT COLD PACK1Cleared 510(K)
- K926589ANAGO WARM PACK1Cleared 510(K)
- K926137ANAGO FEM-COOL/FEM-COOL PETITE1Cleared 510(K)
- K920252CURAD KID SIZE INSTANT COLD PACK1Cleared 510(K)
- K912715INSTANT WARM GEL PACK1Cleared 510(K)
- K904819SHUR-LOCK ICE WRAP SYSTEM1Cleared 510(K)
- K902839LIBERTY HOT PACK AND LIBERTY KOLD PACK1Cleared 510(K)
- K901834INSTANT ICE PACK1Cleared 510(K)
- K9017783M HEAT COMFORT PORTABLE SELF-HEATING PAD1Cleared 510(K)
- K895860MEDI-PACK1Cleared 510(K)
- K894926STAT-PAD1Cleared 510(K)
- K890924THERMO-PACK1Cleared 510(K)
- K890553CP&S DISPOSABLE INSTANT COLD COMPRESS1Cleared 510(K)
- K890554CP&S DISPOSABLE INSTANT SUPER HOT COMPRESS1Cleared 510(K)
- K883966HARE COLD PACK1Cleared 510(K)
- K880871GRABBER WARM PACK/MINI MINI HEATER/FOOT HEATER1Cleared 510(K)
- K873364HYPERTHERM TECHNOLOGIES' HEAT COMPRESS1Cleared 510(K)
- K871168INSTANT COLD COMPRESS, CHEMICAL TYPE1Cleared 510(K)
- K871114INSTANT HEAT COMPRESS, CHEMICAL TYPE1Cleared 510(K)
- K870832OXY-THERM1Cleared 510(K)
- K863507PHYSI. & NURSES BRAND INSTANT KOLD & HOT KOMPRESS1Cleared 510(K)
- K860444MAZING HEAT DISPOSABLE WARM PACK1Cleared 510(K)
- K853148HOT OR HEAT PACK1Cleared 510(K)
- K853045ALLY PORTABLE NOT PACK/PAD DISPOSABLE1Cleared 510(K)
- K852610HOT PACK1Cleared 510(K)
- K850566MARUKYR-BAN / HOT OR HEAT PACK1Cleared 510(K)
- K850637EXOTHERMIC HEATING PAD1Cleared 510(K)
- K844224EIXO THERMUS HEATING PADS1Cleared 510(K)
- K820906SPENCO CRYOPRESS1Cleared 510(K)
- K821046COMPRES PORTABLE HEAT PADS1Cleared 510(K)
- K820359HOT MINI 15 & HOT MINI 241Cleared 510(K)
- K820282ACE BRAND INSTANT COLD PACK1Cleared 510(K)
- K813628BK-7182 INSTANT COLD PACK1Cleared 510(K)
- K811803JAPANESE HOTZIE1Cleared 510(K)
- K811206SELF HEATING DISPOSABLE HEAT PAD1Cleared 510(K)
- K810693CURITY PERINEAL COLD PACK1Cleared 510(K)
- K810692CURITY PERINEAL WARM PACK1Cleared 510(K)
- K810633WONDER WARMER1Cleared 510(K)
- K802252HOT CYCLE, A CHEMICAL TYPE HOT PACK1Cleared 510(K)
- K790993INSTANT HOT & COLD PACKS1Cleared 510(K)
- K791675KWICK KOOLER1Cleared 510(K)
- K790480TULANE HEAT-PACK1Cleared 510(K)
- K780426BODY WARMER1Cleared 510(K)
- K780603COLD PACK1Cleared 510(K)
- K780279ICE-PAK, PDI1Cleared 510(K)
- K780014COLD CYCLE, CHEMICAL COLD PACK1Cleared 510(K)
- K771660KWICK KOOLER1Cleared 510(K)
- K770505SHAKE-N-WARM1Cleared 510(K)
- K760706MUL-T-PAD1Cleared 510(K)
- K760441BODY WARMER (SHAKE-N-WARM)1Cleared 510(K)
- 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
COLDGEL
- Page Type
- Cleared 510(K)
- 510(k) Number
- K953542
- 510(k) Type
- Traditional
- Applicant
- PRISM TECHNOLOGIES, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent for Some Indications
- Decision Date
- 10/30/1995
- Days to Decision
- 94 days
- Submission Type
- Summary