Anesthesiology
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- 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
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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
- 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
- K243783Walking rehabilitation training electric wheelchair (ZW518)2Cleared 510(K)
- K202728Action Trackchair Hawk2Cleared 510(K)
- K203761ParaMotion2Cleared 510(K)
- K191334Tek RMD (TEK ROBOTIC MOBILIZATION DEVICE) TEKRMD02, TEKRMD03, TEKRMD04, TEKRMD04, TEKRMD05, TEKRMD06, TEKRMD07, TEKRMD082Cleared 510(K)
- K190682Explorer Mini2Cleared 510(K)
- K191874F5 Corpus VS2Cleared 510(K)
- K182257UPnRIDE2Cleared 510(K)
- K191376Modular Power Standing System2Cleared 510(K)
- K172384Quickie(r) Q700-UP M2Cleared 510(K)
- K163451Action Trackstander models TR1816, TR1820, TR2016, and TR20202Cleared 510(K)
- K150548Tek RMD (Tek Robotic Mobilization Device)2Cleared 510(K)
- K122562E-TENG MODEL EOR 12Cleared 510(K)
- K102837HIROLLER ELEVATING WHEELCHAIR2Cleared 510(K)
- K102734COMFORT STANDING WHEELCHAIR, HERO SERIES2Cleared 510(K)
- K090256POWER STANDING DANI2Cleared 510(K)
- K083017LEVO C32Cleared 510(K)
- K072475BALDER FINESSE AND JUNIOR POWERED WHEELCHAIRS (WITH STAND-UP OPTION)2Cleared 510(K)
- K071761LLOYD LINDEN, MODEL E042Cleared 510(K)
- K071390WHEELCHAIR MODEL STS2Cleared 510(K)
- K061726LSC, MODEL 32Cleared 510(K)
- K060936PARAGOLFER2Cleared 510(K)
- K052375ALILIFE STAND UP POWERED WHEELCHAIR, HC-3002Cleared 510(K)
- K051387LEVO COMFORT II2Cleared 510(K)
- K042596LSA HELIUM2Cleared 510(K)
- K041535LSC LIFESTAND COMPACT2Cleared 510(K)
- K032101POWERSTAND STAND-UP WHEELCHAIR2Cleared 510(K)
- K031621HERO 1, MODEL LY-ESB2202Cleared 510(K)
- K031618COMFORT VARIOUS OF STANDING WHEELCHAIR, HERO 22Cleared 510(K)
- K030882RABBIT MOBILE STANDING FRAME2Cleared 510(K)
- K030893LEVO COMBI2Cleared 510(K)
- K021165NEW HEIGHTS ELECTRIC ELEVATING POWER WHEELCHAIR MODEL NO. 08 02 SERIES2Cleared 510(K)
- K011530VERTRAN STANDING WHEELCHAIR2Cleared 510(K)
- K012345NEW HEIGHTS ELECTRIC ELEVATING MANUAL WHEELCHAIR2Cleared 510(K)
- K994083STANNAH POWER CHAIR, MODEL 2012Cleared 510(K)
- K984391THE LIBERATOR2Cleared 510(K)
- K973951LEVO COMPACT-EASY LCE2Cleared 510(K)
- K963817LEVO MOBIL LCM2Cleared 510(K)
- K971873LEVO ACTIVE-EASY LAE2Cleared 510(K)
- K970543BOBCAT DX2Cleared 510(K)
- K963816LEVO COMPACT LC2Cleared 510(K)
- K962278SUPERSTAND STAND-UP WHELLCHAIR2Cleared 510(K)
- K940919CHIEF SR2Cleared 510(K)
- K940852CHIEF STANDUP WHEELCHAIR2Cleared 510(K)
- K946110REGAIN STAND-UP WHEELCHAIR2Cleared 510(K)
- K943129ECONOSTAND2Cleared 510(K)
- K943337STANDUP WHEELCHAIR2Cleared 510(K)
- K924314MOBILE STANDING FRAME2Cleared 510(K)
- K922107TAYLOR MADE MOBILE STANDER2Cleared 510(K)
- K921894RIFTON MOBILE PRONE STANDERS2Cleared 510(K)
- K921084THE EXCELSIOR2Cleared 510(K)
- K920463ZIPPIE 3 TS/SP WHEELCHAIR/STANDER2Cleared 510(K)
- K911608GRANSTAND2Cleared 510(K)
- K896904B.A.C. 3000 CHAIR/STANDER2Cleared 510(K)
- K895686DAILY ACTIVITY ASSIST DEVICE (MOBILE STANDING AID)2Cleared 510(K)
- K890695HI-RIDER WHEELCHAIR2Cleared 510(K)
- K890602STANDING DANI WHEELSTAND2Cleared 510(K)
- K884840B.A.C. 1000 MOBILE STANDING DEVICE2Cleared 510(K)
- K884541PRO-VERTIC 2000 STAND-UP/SELF-RISING WHEELCHAIR2Cleared 510(K)
- K872934STAND AID2Cleared 510(K)
- K863118I.D.C. STANDUP WHEELCHAIRS2Cleared 510(K)
- K862305ARISE, VIVRE DEBOUT2Cleared 510(K)
- K862013STANDING WHEELER2Cleared 510(K)
- K841920MAC-MULTI-ADJUSTABLE CHAIR2Cleared 510(K)
- K840626VERTICALIBRE WHEELCHAIR2Cleared 510(K)
- K832696RISER STANDUP WHEELCHAIR2Cleared 510(K)
- K790265LEVO-STAND-UP WHEELCHAIR2Cleared 510(K)
- 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
HERO 1, MODEL LY-ESB220
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K031621
- 510(k) Type
- Traditional
- Applicant
- COMFORT ORTHOPEDIC CO. LTD.
- Country
- Taiwan
- FDA Decision
- Substantially Equivalent
- Decision Date
- 1/22/2004
- Days to Decision
- 244 days
- Submission Type
- Statement