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
- 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
- K250266Ceragem Automatic Thermal Massager (CGM MB-2401)2Cleared 510(K)
- K241193AGILIS - Multi-function Physical Therapy Table (Model: Plus, Pro and Basic.)2Cleared 510(K)
- K243644Ceragem Automatic Thermal Massager (CGM MB-2301 & CGM MB-2302)2Cleared 510(K)
- K243355Ceragem Automatic Thermal Massager (CGM-MB-1902)2Cleared 510(K)
- K240168N7-S2Cleared 510(K)
- K220572Ceragem Automatic Thermal Massager, Model CGM MB-1701 & CGM MB-17022Cleared 510(K)
- K202937Ceragem Automatic Thermal Massager Model CGM-MB-1701 & CGM-MB-17022Cleared 510(K)
- K202113Ceragem Automatic Thermal Massager, Model CGM-MB-19012Cleared 510(K)
- K153054N5-12Cleared 510(K)
- K140592CERAGEM AUTOMATIC THERMAL MASSAGER2Cleared 510(K)
- K111588LEGACY-5002Cleared 510(K)
- K111941CHOYANG THERMAL MASSAGER2Cleared 510(K)
- K102938ACQPOINT THERMAJADE MASSAGE TABLE2Cleared 510(K)
- K111329NM-70002Cleared 510(K)
- K102281THERMAL MASSAGE BED, MODEL 2D-GX2Cleared 510(K)
- K092731VIBRO-TRAC2Cleared 510(K)
- K080554INAREX, MODEL 2D-LX2Cleared 510(K)
- K070672MASSAGE MATTRESS VM9100RM2Cleared 510(K)
- K063034AIR-FLEX WITH AUTO-DISTRACTION2Cleared 510(K)
- K062476CERAGEM RH1 AUTOMATIC THERMAL MASSAGER2Cleared 510(K)
- K040031CERAGEM-C THERMAL ACUPRESSURE MASSAGER2Cleared 510(K)
- K041200THERMASSAGE ENEGRY PRODUCT, MODEL HY-70002Cleared 510(K)
- K032449THERMASSAGE ENERGY PRODUCT, MODEL HY50002Cleared 510(K)
- K010252MAGNUM2Cleared 510(K)
- K002390QUANTUM INTERSEGMENTAL TRACTION TABLE 400, 401, 400H,401H2Cleared 510(K)
- K993461QUEST INTERSEGMENTAL ROLLER TRACTION TABLE2Cleared 510(K)
- K980021EXTENTRAC2Cleared 510(K)
- K974626P.T. MACHINE2Cleared 510(K)
- K971046HANDIFLEX2Cleared 510(K)
- K932810THE HILL ADJUSTABLE AIR-FLEX MODEL2Cleared 510(K)
- K945954MODELS 4100 AND 4300 MULTITHERAPY2Cleared 510(K)
- K943973EURO TECH STERLING ROLLER TABLE2Cleared 510(K)
- K933443COMBI 2.5 INTERSEGMENTAL TRACTION TABLE2Cleared 510(K)
- K924293HERITAGE 102Cleared 510(K)
- K930259TRACTION TABLE MODEL #825-2002Cleared 510(K)
- K926316TRUE-TRAC, STRATUS2Cleared 510(K)
- K922980745-M (MAGNUM)2Cleared 510(K)
- K915784INTERSEGMENTAL TRACTION TABLE2Cleared 510(K)
- K911574PNEU-WAVE2Cleared 510(K)
- K905756TITAN MERIDIAN INTERSEGMENTAL ROLLERTABLE2Cleared 510(K)
- K901971COMFORTRAC TABLE MODEL CT-10002Cleared 510(K)
- K901526PRO TREATMENT TABLE2Cleared 510(K)
- K900304IST-200 INTERSEGMENTAL TRACTION TABLE2Cleared 510(K)
- K895343PRENATAL WEDGE2Cleared 510(K)
- K883357MODEL 1080 ROLLER MASSAGE TABLE2Cleared 510(K)
- K882917HI-LO TABLE, MODEL 820-052Cleared 510(K)
- K881804MULTI-FLEX TABLE--MODEL 2002Cleared 510(K)
- K881902HEALTHTRONIC OMEGA TRAC2Cleared 510(K)
- K870714MULTI-FLEX TABLE -- MODEL 1052Cleared 510(K)
- K870710MULTI-FLEX TABLE -- MODEL 1012Cleared 510(K)
- K870711MULTI-FLEX TABLE -- MODEL 1022Cleared 510(K)
- K870712MULTI-FLEX TABLE -- MODEL 1032Cleared 510(K)
- K870715MULTI-FLEX TABLE -- MODEL 1062Cleared 510(K)
- K870713MULTI-FLEX TABLE -- MODEL 1042Cleared 510(K)
- K870427EXTENSION/OSCILLATOR TABLE2Cleared 510(K)
- K862411THE RELAXARE EXERCISE AND MASSAGE UNIT2Cleared 510(K)
- K862022LIC-ORTHION MULTI-THERAPY TREATMENT TABLE2Cleared 510(K)
- K861554PORT-A-TRAC2Cleared 510(K)
- K851328KINETIC AUTO TECHNIC K.A.T. TABLE2Cleared 510(K)
- K844233AUTOTRACTION TABLE2Cleared 510(K)
- K843572PDB II VIBRATING DRAINAGE BED2Cleared 510(K)
- K832464MASSAGE TABLE AAT-1002Cleared 510(K)
- K831394SOMATRON2Cleared 510(K)
- K822413WEYLAND EXTENSION VIBRATOR2Cleared 510(K)
- K830875S & W MODEL 292Cleared 510(K)
- K822693ACU-MASSAGE TABLE2Cleared 510(K)
- 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
HANDIFLEX
- Page Type
- Cleared 510(K)
- 510(k) Number
- K971046
- 510(k) Type
- Traditional
- Applicant
- HANDIFLEX CORP.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 9/16/1997
- Days to Decision
- 179 days
- Submission Type
- Statement