Anesthesiology
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- General HospitalReview Panel
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- MiscellaneousMiscellaneous
- Subpart B—Physical Medicine Diagnostic DevicesCFR Sub-Part
- Subpart D—Physical Medicine Prosthetic DevicesCFR Sub-Part
- IMKWheelchair, Stair Climbing2Product Code
- IMLArmrest, Wheelchair1Product Code
- IMMFootrest, Wheelchair1Product Code
- IMNClimber, Curb, Wheelchair1Product Code
- IMOHandrim, Wheelchair1Product Code
- IMPCushion, Wheelchair1Product Code
- IMQAttachment, Narrowing, Wheelchair1Product Code
- IMRDevice, Anti-Tip, Wheelchair1Product Code
- QNXExternal Compression Device For Internal Jugular Vein Compression2Product Code
- ILESling, Arm, Overhead Supported1Product Code
- ILGStocking, Elastic1Product Code
- ILHSplint, Hand, And Components1Product Code
- ILISling, Arm1Product Code
- ILPSystem, Communication, Non-Powered1Product Code
- ILQSystem, Communication, Powered2Product Code
- IMSSupport, Head And Trunk, Wheelchair1Product Code
- IMWBrake, Extension, Wheelchair1Product Code
- IMXBoard, Lap, Wheelchair1Product Code
- IMYArmboard, Wheelchair1Product Code
- IMZHolder, Crutch And Cane, Wheelchair1Product Code
- INAHill Holder, Wheelchair1Product Code
- INBAttachment, Commode, Wheelchair1Product Code
- INCCuff, Pusher, Wheelchair1Product Code
- INESling, Overhead Suspension, Wheelchair1Product Code
- INFScale, Platform, Wheelchair1Product Code
- INGElevator, Wheelchair, Portable2Product Code
- INIVehicle, Motorized 3-Wheeled2Product Code
- INKStretcher, Wheeled, Powered2Product Code
- INMChair, With Casters1Product Code
- INNChair, Adjustable, Mechanical1Product Code
- INOChair, Positioning, Electric2Product Code
- K131909DALTON LIFT CHAIR2Cleared 510(K)
- K123834EASYSTAND BANTAM MEDIUM2Cleared 510(K)
- K112944FRESENIUS MEDICAL TREATMENT CHAIR T688 SERIES2Cleared 510(K)
- K101723COMPACT WHEELCHAIR PLATFORM2Cleared 510(K)
- K091578LIFT CHAIR, MODEL T32Cleared 510(K)
- K091727MEDICAL TREATMENT CHAIR, T400, T500,T6002Cleared 510(K)
- K091242BANTAM2Cleared 510(K)
- K073565STANDARD WHEELCHAIR PLATFORM2Cleared 510(K)
- K081053PIVOT ASSIST2Cleared 510(K)
- K080533WINCO MODEL POWER SERIES LIFT CHAIR2Cleared 510(K)
- K071793CONVERTIBLE I-SERIES POSITIONING AND TRANSFER CHAIR2Cleared 510(K)
- K070950LIFT CHAIR, MODEL C52Cleared 510(K)
- K062402EASYSTAND EVOLV2Cleared 510(K)
- K060212MERITS MODEL E SERIES LIFT CHAIRS2Cleared 510(K)
- K031045AEROLET TOILET LIFT, MODEL AER-012Cleared 510(K)
- K023521EASY LIFE2Cleared 510(K)
- K022407MULTI FUCTIONAL REHABILITATION CHAIR2Cleared 510(K)
- K002318UNITED #1018-FREEDOM SERIES, UNITED #2018-COMFORT SERIES, UNITED #3018-ELEGANCE SERIES, UNITED #5018-MASTER SERIES2Cleared 510(K)
- K001937MEDLINE ELECTRONIC POSITIONING CHAIR2Cleared 510(K)
- K002171INVACARE LIFT CHAIR2Cleared 510(K)
- K991693TWO RIVERS POWER LIFT/RECLINE CHAIR2Cleared 510(K)
- K973373PREVENT I2Cleared 510(K)
- K961663ELECTRIC SEAT LIFT CHAIR2Cleared 510(K)
- K953342TMR482Cleared 510(K)
- K945257577ES (ERGOSENSE)2Cleared 510(K)
- K943330ACTION-LIFT CHAIR2Cleared 510(K)
- K931349TMR-6702Cleared 510(K)
- K925652UNIVERSAL WHEELCHAIR LIFT2Cleared 510(K)
- K930262TREATMENT TABLE, MODEL #825-1002Cleared 510(K)
- K923804PORTABLE LIFT SEAT2Cleared 510(K)
- K912320BIOPHYSIOMETER POSITIONING CHAIR2Cleared 510(K)
- K903905SERIES 9000 LIFT-RECLINE CHAIR2Cleared 510(K)
- K902795MODIFIED CHAIRS (DENTAL, MEDICAL, AND PODIATRY)2Cleared 510(K)
- K900307KARE CHAIR I2Cleared 510(K)
- K884123AMOS BOY LIFT CHAIR2Cleared 510(K)
- K881298ASSIST-A-LIFT2Cleared 510(K)
- K880861MECHANICAL ADJUSTABLE CHAIR (AC POWERED)2Cleared 510(K)
- K880398POWER TOILET ELEVATOR2Cleared 510(K)
- K880800GOLDEN POWER LIFT CHAIR2Cleared 510(K)
- K880786BUSHLINE CARE CHAIR2Cleared 510(K)
- K864918HEALTH PRODUCTS, INC. ORTHODERM THERAPY CHAIR2Cleared 510(K)
- K864366COMFORT+LIFT CHAIR2Cleared 510(K)
- K862857FRANKLIN CHAIRS/MOVES, #4000 SERIES & #4100 SERIES2Cleared 510(K)
- K862654MODIFIED PENOX LIFT CHAIR2Cleared 510(K)
- K852812COMFORT + LIFT2Cleared 510(K)
- K852864GENTLE LIFT-RECLINER CHAIR2Cleared 510(K)
- K851218PENOX LIFT CHAIR2Cleared 510(K)
- K850873HILO TABLES, TYPE CH-4, CH-8, FW-6, FW-5, FW-2, AL2Cleared 510(K)
- K844025CONTOUR CHAIR LOUNGE W/OPTIIONAL HEAT & MASSAGE2Cleared 510(K)
- K832224NOVA LIFT CHAIR2Cleared 510(K)
- K821827GENTLE-LIFT CHAIR2Cleared 510(K)
- K802803CONVALESCENT RECLINER2Cleared 510(K)
- K781559LIFTING CHAIR & LIFTING LAVATORY SEAT2Cleared 510(K)
- INPTips And Pads, Cane, Crutch And Walker1Product Code
- INQTable, Powered1Product Code
- INTPlinth1Product Code
- INWTable, Mechanical1Product Code
- IORWheelchair, Mechanical1Product Code
- IOYSupport, Arm1Product Code
- IOZSplint, Abduction, Congenital Hip Dislocation1Product Code
- IPGShoe, Cast1Product Code
- IPLWheelchair, Standup2Product Code
- IPMCover, Limb1Product Code
- IPOOrthosis, Pneumatic Structure, Rigid3Product Code
- IPRCrutch1Product Code
- IPSCane1Product Code
- IPTOrthosis, Thoracic1Product Code
- IPWOrthosis, Sacroiliac, Soft1Product Code
- IPXOrthosis, Rib Fracture, Soft1Product Code
- IPYOrthosis, Lumbo-Sacral1Product Code
- IQASystem, Environmental Control, Powered2Product Code
- IQBBelt, Wheelchair1Product Code
- IQCWheelchair, Special Grade2Product Code
- IQEOrthosis, Lumbar1Product Code
- IQFOrthosis, Cervical-Thoracic, Rigid1Product Code
- IQIOrthosis, Limb Brace1Product Code
- IQJSplint, Clavicle1Product Code
- IQKOrthosis, Cervical1Product Code
- IQMSplint, Temporary Training1Product Code
- IQODevice, Prosthesis Alignment1Product Code
- IQPRotator, Transverse1Product Code
- IQQJoint, Shoulder, External Limb Component1Product Code
- IQWHook, External Limb Component, Powered1Product Code
- IQXHook, External Limb Component, Mechanical1Product Code
- IQZHand, External Limb Component, Powered1Product Code
- IRAHand, External Limb Component, Mechanical1Product Code
- IRDJoint, Elbow, External Limb Component, Mechanical1Product Code
- IREJoint, Elbow, External Limb Component, Powered1Product Code
- ISHComponent, External, Limb, Ankle/Foot1Product Code
- ISLJoint, Hip, External Limb Component1Product Code
- ISMPylon, Post Surgical1Product Code
- ISNCable1Product Code
- ISPValve, Prosthesis1Product Code
- ISRBand Or Belt, Pelvic Support1Product Code
- ISSProsthesis, Thigh Socket, External Component1Product Code
- ISWAssembly, Knee/Shank/Ankle/Foot, External2Product Code
- ISYJoint, Knee, External Limb Component1Product Code
- ISZUnit, Wrist, External Limb Component, Mechanical1Product Code
- ITCStirrup, External Brace Component1Product Code
- ITGBandage, Cast1Product Code
- ITIWheelchair, Powered2Product Code
- ITJWalker, Mechanical1Product Code
- ITMCage, Knee1Product Code
- ITNSplint, Denis Brown1Product Code
- ITOTwister, Brace Setting1Product Code
- ITQJoint, Knee, External Brace1Product Code
- ITSJoint, Hip, External Brace1Product Code
- ITWJoint, Ankle, External Brace1Product Code
- KFTAssembly, Shoulder/Elbow/Forearm/Wrist/Hand, Mechanical1Product Code
- KFWAssembly, Shoulder/Elbow/Forearm/Wrist/Hand, Powered1Product Code
- KFXAssembly, Thigh/Knee/Shank/Ankle/Foot, External2Product Code
- KGHUnit, Wrist, External Limb Component, Powered1Product Code
- KHYCane, Safety Walk1Product Code
- KICCushion, Flotation1Product Code
- KIDRestraint, Wheelchair, Non-Protective1Product Code
- KNNComponents, Wheelchair1Product Code
- KNOAccessories, Wheelchair1Product Code
- KNPOrthosis, Corrective Shoe1Product Code
- KTDOrthosis, Abdominal1Product Code
- LBEStroller, Adaptive1Product Code
- LFFUnit, Activation, Breath Control1Product Code
- MNEOrthosis, Moldable, Supportive, Skin Protective1Product Code
- MRIOrthosis, Truncal/Orthosis, Limb1Product Code
- NDAHelmet, Cranial, For Protective Use1Product Code
- NHFMonitor, Orthotic/Prosthetic1Product Code
- NJBOrthosis, Truncal, For Dysmenorrhea1Product Code
- NXEWalker, Mechanical, Poly Vinyl Chloride (Pvc)1Product Code
- OHIOrthosis, Foot Drop1Product Code
- PAEUpper Extremity Prosthesis With Multiple Simultaneous Degrees Of Freedom And Controlled Via Cutaneous Electromyography2Product Code
- PCEPermanently Mounted Wheelchair Platform Lift2Product Code
- PMVOrthosis, Limb, For Back Pain1Product Code
- QDTShoe With Adjustable Sole Units1Product Code
- Subpart E—Surgical DevicesCFR Sub-Part
- Subpart F—Neurological Therapeutic DevicesCFR Sub-Part
- Subpart F—Physical Medicine Therapeutic DevicesCFR Sub-Part
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
577ES (ERGOSENSE)
- Page Type
- Cleared 510(K)
- 510(k) Number
- K945257
- 510(k) Type
- Traditional
- Applicant
- LUMEX, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 4/26/1995
- Days to Decision
- 180 days
- Submission Type
- Summary