Anesthesiology
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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
- 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
- K211919KISS Dynamic Back Support, KISS Dynamic Solid Drop Seat1Cleared 510(K)
- K942310DYNASTY GC 12550 (GELL/CELL)1Cleared 510(K)
- K942309DYNASTY U1-31 (GELL/CELL)1Cleared 510(K)
- K942311DYNASTY U1-33 AGM1Cleared 510(K)
- K942308DYNASTY GC 12400 (GELL/CELL)1Cleared 510(K)
- K942312ALDEN LINEAGE WHEELCHAIR CUSHION1Cleared 510(K)
- K942260ALDEN WHEELCHAIR CUSHION1Cleared 510(K)
- K933051ZERO GRAVITY WHEELCHAIR COMPONENTS, MODIFICATION1Cleared 510(K)
- K925980PM1Cleared 510(K)
- K923942RHOMBO MEDICAL RHOMBO-FILL1Cleared 510(K)
- K923364TILT ADJUSTABLE SLIDING BACK RECLINE SEATING SYST1Cleared 510(K)
- K925336VALU-PLUS PAD1Cleared 510(K)
- K923366TILT SEATING SYSTEM1Cleared 510(K)
- K923186NEXUS WHEELCHAIR CUSHION/FORMERLY BIOTHOTIC1Cleared 510(K)
- K921369BIOMEDICAL HORIZONS MODEL 10011Cleared 510(K)
- K921027MANUAL CHAIR BASE1Cleared 510(K)
- K915629CUSHION, WHELCHAR AND FLOTATION1Cleared 510(K)
- K915368SERENA WHEELCHAIR CUSHIONS1Cleared 510(K)
- K913545PIN DOT FLIP-DOWN ABDUCTOR1Cleared 510(K)
- K913546IMPALA CASTERS1Cleared 510(K)
- K913549PIN DOT MOUNTING BRACKETS1Cleared 510(K)
- K913553PIN DOT GROWTH/DIAL LINKS1Cleared 510(K)
- K913548PIN DOT ALUMINUM PAN1Cleared 510(K)
- K913550PIN DOT TRUNION MOUNTS1Cleared 510(K)
- K913509IMPALA WHEELS1Cleared 510(K)
- K913511IMPALA AXLES1Cleared 510(K)
- K913507ARMREST1Cleared 510(K)
- K913552PIN DOT FOOTREST PRODUCTS1Cleared 510(K)
- K905013T.C.S. TOTAL CONTACT SEAT1Cleared 510(K)
- K904913HANDI-TRAK WHEELCHAIR SNOW CHAINS1Cleared 510(K)
- K900839THE CAROLINA ROCKER1Cleared 510(K)
- K894770PERSONAL BACK WITH FIP KIT1Cleared 510(K)
- K890178WHEELCHAIR STUMP SUPPORT1Cleared 510(K)
- K894960E.Z. LOCK WHEELCHAIR RESTRAINT DEVICE1Cleared 510(K)
- K885104LAYDOWN ARM SUPPORT MECHANISM1Cleared 510(K)
- K885105SLIDING ARM SUPPORT1Cleared 510(K)
- K885106REMOVABLE BATTERY POWER SYSTEM1Cleared 510(K)
- K884052GILLUM'S WHEELCHAIR WIDTH REDUCING ATTACHMENT1Cleared 510(K)
- K883679WHEELS-OFF QUICK RELEASE AXLE SYSTEM1Cleared 510(K)
- K882253STOUTE'S ASSIST-SEAT WHEELCHAIR COMPONENT1Cleared 510(K)
- K882012LIFESTYLE SOF. CARE GEL CHAIR CUSHION1Cleared 510(K)
- K870698VAN-TEC PROSTATE BIOPSY NEEDLE1Cleared 510(K)
- K870299REDMAN UPHOLSTERY SERIES FOR WHEELCHAIRS1Cleared 510(K)
- K863385(ROTH)SPIRAL ROTATING PROSTATIC BIOPSY NEEDLE1Cleared 510(K)
- K862887UPHOLSTERED BUCKET SEAT1Cleared 510(K)
- K861754KINESETHETIC SEATING SYSTEM/WHEELCHAIR1Cleared 510(K)
- K861755SHS CUSHION/WHEELCHAIR1Cleared 510(K)
- K861751THE FITZ KIT, MOLDED/CUSTOM WHEELCHAIR SEATING SYS1Cleared 510(K)
- K854710BOTTOMS-UP TM PELVIC SPINAL POSTURE-AID1Cleared 510(K)
- K855181COMFORTEX WHEELCHAIR CUSHION1Cleared 510(K)
- K840629WHEELCHAIR ACCESSORIES1Cleared 510(K)
- K823638ARM THROUGH FOR WHEELCHAIR BK 6454-01 &1Cleared 510(K)
- K823637ARM THROUGH FOR WHEELCHAIR BK-6458-011Cleared 510(K)
- K823875CHAIN KIT1Cleared 510(K)
- K823874BERKELEY BRAKE1Cleared 510(K)
- K823873CHAIN SILENCER1Cleared 510(K)
- K823877BERKELEY HARNESS1Cleared 510(K)
- K823876BERKELEY FORK1Cleared 510(K)
- K821488ELECATH PORTAL VEIN/BILIARY DRAIN ASSM1Cleared 510(K)
- K820761PALM BEACH SEATING SYSTEM1Cleared 510(K)
- K813636BK-6470 ADJUSTABLE ELEVATING WHEELCHAIR1Cleared 510(K)
- K812348DESK ARM WHEELCHAIR ARM EXTENSION1Cleared 510(K)
- K780192LEGREST, ELEVATING1Cleared 510(K)
- K771631WHEELCHAIR SAFETY BELT1Cleared 510(K)
- 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
BIOMEDICAL HORIZONS MODEL 1001
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K921369
- 510(k) Type
- Traditional
- Applicant
- BIOMEDICAL HORIZONS, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 5/11/1992
- Days to Decision
- 52 days
- Submission Type
- Statement