Anesthesiology
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- 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
- K242041STOPWET iontophoresis apparatus (SW01)2Cleared 510(K)
- K241267Hidroxa SE302Cleared 510(K)
- K232020Iontophoresis Electrodes2Cleared 510(K)
- K192749Dermadry2Cleared 510(K)
- K191436Saalio2Cleared 510(K)
- K170835Electro Antiperspirant, Electro Antiperspirant Sensitive, Electro Antiperspirant ELITE2Cleared 510(K)
- K170291IontoDC2Cleared 510(K)
- K150453TULA Iontophoresis System with Earset2Cleared 510(K)
- K133033HIDREX PSP10002Cleared 510(K)
- K132832ACTIVAPATCH ET IONTOPHORESIS PATCH2Cleared 510(K)
- K110636TULA IONTOPHORESIS SYSTEM2Cleared 510(K)
- K083016ACTHYDERM2Cleared 510(K)
- K091326ACTIVAPATCH2Cleared 510(K)
- K080580COMFORT IONTOPHORESIS ELECTRODES/ BUFFERED IONTOPHORESIS ELECTRODE TREATMENT, MODEL SMALL DDS275, MEDIUM DDM325, LARGE D2Cleared 510(K)
- K073276IONTOPHORESIS SYSTEM2Cleared 510(K)
- K072946HYBRESIS IONTOPHORESIS DRUG DELIVERY SYSTEM2Cleared 510(K)
- K070427DUPEL TRANSPORT IONTOPHORESIS SYSTEM2Cleared 510(K)
- K061849MESODERM2Cleared 510(K)
- K062792ERCHONIA IOTO_2402Cleared 510(K)
- K063465CHAMPION IONTOPHORETIC DRUG DELIVERY DEVICE2Cleared 510(K)
- K061522TRIVARION BUFFERED IONTOPHORESIS ELECTRODE SYSTEM2Cleared 510(K)
- K060814DYNATRON ION IONTOPHORESIS ELECTRODE2Cleared 510(K)
- K060579COMFORT/IO IONTOPHORESIS ELECTRODES2Cleared 510(K)
- K060236MW-1000 IONTOPHORETIC DRUG DELIVERY ELECTRODE2Cleared 510(K)
- K052019NORTH COAST BUFFERED IONTOPHORESIS ELECTRODE2Cleared 510(K)
- K043047DYNATRON IBOX IONTOPHORESIS DEVICE2Cleared 510(K)
- K042590TRANSDERM IONTO SYSTEM, MK 22Cleared 510(K)
- K041101MEDICAL ADHESIVEONLINE, LLC. IONTOPHORESIS DRUG DELIVERY ELECTRODES, MODELS 23001, 23002, 23003, 23004, AND 240012Cleared 510(K)
- K040495NAIMCO, INC., IONTOPHORESIS DRUG DELIVERY ELECTRODES, MODELS 201-400, 201-401, 201-402, 201-403 AND 201-4052Cleared 510(K)
- K032968TRSANSDERM IONTO SYSTEM2Cleared 510(K)
- K031769E-STRIP2Cleared 510(K)
- K031053SELECTIVE MED COMPONENTS, INC. BUFFERED IONTOPHORESIS DRUG DELIVERY SYSTEM ELECTRODES, MODELS I20, I30, I40, I50, AND I72Cleared 510(K)
- K022950MINIPHYSIONIZER 2.0 AND ELECTRODES2Cleared 510(K)
- K030395EMPI ACTION PATCH IONTOPHORESIS SYSTEM2Cleared 510(K)
- K020476MEDION 60002Cleared 510(K)
- K000574IONTOPHORETIC DRUG DELIVERY ELECTRODE, IONTOPHORETIC ELECTRODE (ACTIVE)2Cleared 510(K)
- K993081IO-DRIVE2Cleared 510(K)
- K992708IONTOPATCH2Cleared 510(K)
- K991991DUPEL IONTOPHORESIS SYSTEM2Cleared 510(K)
- K982668PHORESOR II,MODEL PM9002Cleared 510(K)
- K983484DUPEL B.L.U.E. SMALL IONTOPHORESIS ELECTRODE2Cleared 510(K)
- K970491DUPEL II BUFFERED IONTOPHORESIS ELECTRODES2Cleared 510(K)
- K964208MD-1A GALVANIC UNIT2Cleared 510(K)
- K946337IT-727 (ALSO KNOWN AS IT-610, IT-600 AND DYNAPHOR II2Cleared 510(K)
- K935868DYNAPHOR(TM) TWO2Cleared 510(K)
- K934335PHORESOR II AUTO, MODEL PM800 MODIFICATION2Cleared 510(K)
- K932621RH-801/GS MODEL TRANSQ(R)12Cleared 510(K)
- K932620RH-806/GS MODEL TRANSQ(R)22Cleared 510(K)
- K915444DUPEL IONTOPHORESIS DEVICE2Cleared 510(K)
- K913601MICROPHOR2Cleared 510(K)
- K925800RH-806, MODEL TRANSQ2Cleared 510(K)
- K925806RH-801, MODEL TRANSQ2Cleared 510(K)
- K914264TRANSQ 22Cleared 510(K)
- K914621IONTOPHORESIS DEVICE, MODIFICATION2Cleared 510(K)
- K912015TBD, EMPI BUFFERED IONTOPHORESIS ELECTRODED MDL. 32Cleared 510(K)
- K912014TBD, EMPI BUFFERED IONTOPHORESIS ELECTRODES MDL. 22Cleared 510(K)
- K903093IONTOPHORESIS DEVICE2Cleared 510(K)
- K895365MD-2 IONTOPHORESIS UNIT2Cleared 510(K)
- K896444IONTOPHORESIS DEVICE - ELECTRODE RH 8002Cleared 510(K)
- K900363NEOPHOR-MC2Cleared 510(K)
- K896703TBD IONTOPHORESIS ELECTRODE2Cleared 510(K)
- K894549DYNAPHOR(TM) 101, IONTOPHORESIS DEVICE2Cleared 510(K)
- K884834XOMED IONESTHETIZER(TM)2Cleared 510(K)
- K882554MEDITRODE KIT2Cleared 510(K)
- K871869MODIFIED USE FOR MODEL 6110A IONTOPHORETIC APPLI.2Cleared 510(K)
- K872040PHORESOR II (TM), MODEL PM7002Cleared 510(K)
- K863166MODEL 6110 IONTOPHORETIC APPLICATOR2Cleared 510(K)
- K853635SUBDERM TM2Cleared 510(K)
- K850508LOGIKAL LONTOPHORESIS UNIT -ANESTHESIA INOTOPHORES2Cleared 510(K)
- K842483SANTA BARBARA MEDCO-LANTOPHORETIC APPLIC2Cleared 510(K)
- K831320DRIONIC2Cleared 510(K)
- K770717IONTOPHORESIS SYSTEM MODULE, DM 5002Cleared 510(K)
- K771130DESENSITRON2Cleared 510(K)
- 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
- 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
COMFORT/IO IONTOPHORESIS ELECTRODES
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K060579
- 510(k) Type
- Abbreviated
- Applicant
- PEPIN MFG., INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 4/20/2006
- Days to Decision
- 45 days
- Submission Type
- Summary