Anesthesiology
Review Panel
- CardiovascularReview Panel
- 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
- OphthalmicReview Panel
- OrthopedicReview Panel
- PathologyReview Panel
- Physical MedicineReview Panel
- 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
- K250758Electric Wheelchair (F309)2Cleared 510(K)
- K243110eFOLDi Navigator Powerchair (STPC-A)2Cleared 510(K)
- K250158Electric Wheelchair (ZH-W001,ZH-W002 ,ZH-W003)2Cleared 510(K)
- K250748KLAXON (TWIST); KLAXON (TWIST R)2Cleared 510(K)
- K250366Electric Wheelchair (LW01301A07)2Cleared 510(K)
- K242358Powered wheelchair (mobility robot) (M4, M4U)2Cleared 510(K)
- K250134Power Wheelchair (YH-E6011,YH-E6013A)2Cleared 510(K)
- K244003Electrically powered wheelchair2Cleared 510(K)
- K243970Portable Wheelchair2Cleared 510(K)
- K241159Handbike Batec Electric2Cleared 510(K)
- K243961Electrically Powered Wheelchair2Cleared 510(K)
- K243962Electrically Powered Wheelchair2Cleared 510(K)
- K241641Electric Wheelchair (YE200)2Cleared 510(K)
- K240267Klaxon (Twist); Klaxon (Twist R)2Cleared 510(K)
- K242448Power Wheelchair (D03, D05, D06, D09, D11, D16, D22, D23, D26, D36)2Cleared 510(K)
- K242989Electric Wheelchair (MODEL H)2Cleared 510(K)
- K242468Power Wheelchair (D10, D12, D15, D17, D20, D37)2Cleared 510(K)
- K242252Power Wheelchair2Cleared 510(K)
- K243440Electric Wheelchair (HC820N)2Cleared 510(K)
- K242327Empulse M902Cleared 510(K)
- K242308Power wheelchair2Cleared 510(K)
- K241588Electric Wheelchair (KR8803)2Cleared 510(K)
- K241529Powered Wheelchair (NXN20-209)2Cleared 510(K)
- K241603Powered Wheelchair (NXN20-208, NXN20-211)2Cleared 510(K)
- K242471Power Wheelchair (W5538)2Cleared 510(K)
- K242402Power wheelchair2Cleared 510(K)
- K242791Electric wheelchair (KR-8807)2Cleared 510(K)
- K242430Power-Flex (PFX1214); Power-Flex (PFX1517); Power-Flex (PFX1820)2Cleared 510(K)
- K241189Electric Wheelchair (ME23-EW16-BC200-01); Electric Wheelchair (ME23-EW16-BC200-02)2Cleared 510(K)
- K241337Electrically powered wheelchair (HP202)2Cleared 510(K)
- K241632Electrically powered wheelchair2Cleared 510(K)
- K240563Power Wheelchair (JJW-6001)2Cleared 510(K)
- K241854Power Wheelchair2Cleared 510(K)
- K240331Electric wheelchair (YHWL002, YHWL003)2Cleared 510(K)
- K241379Powered Wheelchair (NXN20-205, NXN20-205M)2Cleared 510(K)
- K240638Power Wheelchair (YH-E7007)2Cleared 510(K)
- K242136Electric wheelchair (C001)2Cleared 510(K)
- K241723Electric wheelchair (W3902)2Cleared 510(K)
- K241721Electric wheelchair (N3901)2Cleared 510(K)
- K240105Navigator (FMNVG15); Navigator XL (FMNVX06)2Cleared 510(K)
- K240270Electric wheelchair (S7018)2Cleared 510(K)
- K241686Power wheelchair (N6101)2Cleared 510(K)
- K240079Electric Wheelchair (Panda 10); Electric Wheelchair (Panda 12)2Cleared 510(K)
- K240255Electric Wheelchair (JLE-W01A-2023)2Cleared 510(K)
- K240339Electric Wheelchair (Robooter E60) (BBR-E60-01); Electric Wheelchair (Robooter E60) (BBR-E60-02); Electric Wheelchair (Robooter E60) (BBR-E60-03); Electric Wheelchair (Robooter E60) (BBR-E60-04); Electric Wheelchair (Robooter E60) (BBR-E60-05); Electric Wheelchair (Robooter E60) (BBR-E60-06); Electric Wheelchair (Robooter E60) (BBR-E60-07); Electric Wheelchair (Robooter E60) (BBR-E60-08)2Cleared 510(K)
- K241463Electric Wheelchair (MP201C); Electric Wheelchair (MP201L)2Cleared 510(K)
- K241154Electric Wheelchair (YFWB-63)2Cleared 510(K)
- K240673Electric wheelchair2Cleared 510(K)
- K240913Electric Wheelchair (HBLD3-B); Electric Wheelchair (HBLD3-E)2Cleared 510(K)
- K240329Electric wheelchair (YHW001-C;YHW001-D;YHW001-E;YHW001-F)2Cleared 510(K)
- K233877XT Series Power Wheelchair (XT2), XT Series Power Wheelchair (XT4)2Cleared 510(K)
- K232783Power wheelchair (Model: JMPW-01W)2Cleared 510(K)
- K231315Velox Power Chair2Cleared 510(K)
- K230964Power Wheelchair (N5909)2Cleared 510(K)
- K231508Power Wheelchair, W55212Cleared 510(K)
- K231868Electric Wheelchair (Robooter E40), Model name: BBR-E40-012Cleared 510(K)
- K232193Electrically Power Wheelchairs (Models:YLB-W-0812-A01, YLB-W-0812-A02, YLB-W-0812-A03)2Cleared 510(K)
- K232121Power wheelchair (Model:BC-EA8000)2Cleared 510(K)
- K201869Ki Power Tilt System2Cleared 510(K)
- K231032AMP by Method Mobility, AMP Plus (or +) by Method Mobility2Cleared 510(K)
- K223393Electric Wheelchair2Cleared 510(K)
- K222502KLICK (VARIANTS: POWER, RACE, MONSTER)2Cleared 510(K)
- K220156Electrically Powered Wheelchair, Joy Rider2Cleared 510(K)
- K221799Electric Wheelchair, Model: 9000N2Cleared 510(K)
- K220827Electric Wheelchair2Cleared 510(K)
- K221026Power Wheelchair2Cleared 510(K)
- K221438WHILL Model F2Cleared 510(K)
- K221215e-motion M252Cleared 510(K)
- K220740Power Wheelchair, W5907 (Q50 R Carbon)2Cleared 510(K)
- K220747Power Wheelchair (N5515B)2Cleared 510(K)
- K212092Portable Folding Electric Wheelchair (Model: DC01)2Cleared 510(K)
- K220213Empulse R902Cleared 510(K)
- K220529Merits P335 Powered Wheelchair2Cleared 510(K)
- K191105e-Throne Folding Wheelchair, Model: ET-12F222Cleared 510(K)
- K212503HP458E Electrically Powered Wheelchair2Cleared 510(K)
- K212854Powered Wheelchair2Cleared 510(K)
- K211647HP358EA Electrically Powered Wheelchair2Cleared 510(K)
- K213090Frontier Series Power Wheelchairs2Cleared 510(K)
- K213383WHILL Model C22Cleared 510(K)
- K201855Electrically Powered Wheelchair -Model HP358E2Cleared 510(K)
- K200423Electric Wheelchair (XW-LY001)2Cleared 510(K)
- K192739Electric Wheelchair [Models: JRWD6010/JRWD6012]2Cleared 510(K)
- K211574Extreme X82Cleared 510(K)
- K203806JWX-1 Plus (Navigo 16/Navigo 24)2Cleared 510(K)
- K202506Karma Powered Wheelchair2Cleared 510(K)
- K200978Electric Wheelchair (Model: S7110)2Cleared 510(K)
- K202632Electric wheelchair (S7204/S7205)2Cleared 510(K)
- K202379Invacare AVIVA Storm RX Power Chair2Cleared 510(K)
- K202482Y207 Electric Wheelchair2Cleared 510(K)
- K203083Magic 360 Power Wheelchair2Cleared 510(K)
- K200857Electric wheelchair (Model: S7012)2Cleared 510(K)
- K192618e-Motion M252Cleared 510(K)
- K193599BOUNDER 300 Power Wheelchair, BOUNDER Plus 300 Power Wheelchair, BOUNDER 450 Power Wheelchair, BIG BOUNDER 600 Power Wheelchair, BIG BOUNDER 1000 Power Wheelchair2Cleared 510(K)
- K192016SMOOV O102Cleared 510(K)
- K182400Solax Powered Wheelchair (Models: S7101, S7103)2Cleared 510(K)
- K192216Invacare AVIVA FX Power Wheelchair, Model: IFX-20MP2Cleared 510(K)
- K182576Solax Powered Wheelchair2Cleared 510(K)
- K182995Bariatric Power Positioning System (BPPS)2Cleared 510(K)
- K181163Wu's Powered Wheelchair2Cleared 510(K)
- K182946Invacare TDX SP2-HD with Captain's Seat2Cleared 510(K)
- K181908Action Trackchair2Cleared 510(K)
- K173315SupaChair Powered Wheelchair2Cleared 510(K)
- K173313SupaChair Powered Wheelchair: COMBI 18, COMBI 18SP, COMBI 20, COMBI 20SP2Cleared 510(K)
- K170787Powered Wheelchair DYW30A(D09)2Cleared 510(K)
- K170507Invacare® TDX® SP2 Power Wheelchair; TDXSP2 TDX SP2 with LiNX Electronics, TDXSP2-CG TDX SP2 Base for Single Act. System w/ Ultra Low Maxx, TDXSP2-MCG TDX SP2 Base for Multiple Actuator System w/ Ultra Low Maxx2Cleared 510(K)
- K163204A08 Power wheelchair2Cleared 510(K)
- K160139Luggie Chair2Cleared 510(K)
- K161241e-fix E35/E362Cleared 510(K)
- K153636Liberator Powered Wheelchair with Solar Companion2Cleared 510(K)
- K160031Quickie Pulse (Models 6BC, 6SC, 6CC, 5BC, 5CC, 6MPC) and Zippie ZM-310 (Models BC, SC)2Cleared 510(K)
- K151717twion2Cleared 510(K)
- K153543WHILL Model M2Cleared 510(K)
- K152672Cajun Commando 4x42Cleared 510(K)
- K151199SmartDrive Wheelchair Power Assist2Cleared 510(K)
- K143383Q6 Edge EM2Cleared 510(K)
- K150574Modular Power Positioning System2Cleared 510(K)
- K142783HEARTWAY Electrically Powered Wheelchair P272Cleared 510(K)
- K142770Powered Wheelchair2Cleared 510(K)
- K143180F32Cleared 510(K)
- K143014F52Cleared 510(K)
- K142731HEARTWAY Electrically Powered Wheelchairs2Cleared 510(K)
- K140706LEVO MAX2Cleared 510(K)
- K141783TDX SP2 POWER WHEECHAIR2Cleared 510(K)
- K142457Quickie, Zippie2Cleared 510(K)
- K142027888 WNLE POWERED WHEELCHAIR2Cleared 510(K)
- K140204JWX-22Cleared 510(K)
- K132856HEARTWAY POWER WHEELCHAIR2Cleared 510(K)
- K130982LERADO, POWER WHEELCHAIR2Cleared 510(K)
- K123769ZX-I POWER ADD ON2Cleared 510(K)
- K122741HOVEROUND TEKNIQUE2Cleared 510(K)
- K122707HOVERROUND TEKNIQUE2Cleared 510(K)
- K123290M300 & M4002Cleared 510(K)
- K122357MERITS MODEL P322FWD POWERED WHEELCHAIR2Cleared 510(K)
- K120405WALK ON WHEELS HS-3500 ELECTRIC AISLE WHEELCHAIR2Cleared 510(K)
- K113621SMARTDRIVE WHEELCHAIR POWER-ASSIST2Cleared 510(K)
- K113577MERITS MODEL R SERIES POSITIONING SYSTEM FOR POWERED WHEELCHAIR2Cleared 510(K)
- K113488JAZZY ELITE 62Cleared 510(K)
- K113463POWER WHEELCHAIR2Cleared 510(K)
- K112815QUANTUM BARIATRIC 4512Cleared 510(K)
- K111278Z10 WHEELCHAIR PUSH AND BRAKE ASSIST DEVICE2Cleared 510(K)
- K111095BREEZE ELECTRIC TRANSPORT CHAIR MODEL 10252Cleared 510(K)
- K110036FX 222-02 POWERED WHEELCHAIR2Cleared 510(K)
- K103477PERMOBIL M300 / M4002Cleared 510(K)
- K102355ZIP'R MANTIS POWERED WHEELCHAIR2Cleared 510(K)
- K101611RELAY POWER WHEELCHAIR2Cleared 510(K)
- K101524C2000 POWERED WHEELCHAIR2Cleared 510(K)
- K100527HOVEROUND TEKNIQUE, MODEL HD-62Cleared 510(K)
- K100350HOVEROUND TEKNIQUE GT POWER WHEELCHAIR, MODEL# TEKNIQUE GT2Cleared 510(K)
- K100327HEARTWAY POWER CHAIR, P232Cleared 510(K)
- K092936AMIGO ESCORT 7.5, MODEL 760001 PHS2Cleared 510(K)
- K092961JAZZY FRONTIE2Cleared 510(K)
- K092225AMYPOWER ALL TRACK SERIES POWER WHEELCHAIR2Cleared 510(K)
- K092130RASCAL WE GO 250 POWERED WHEELCHAIR2Cleared 510(K)
- K091723FREEDOM SCIENCES MOTION CONTROL MODULE VERSION 1.52Cleared 510(K)
- K090350EXTREME 4X4-X8 POWER WHEELCHAIR2Cleared 510(K)
- K090108HOVEROUND TEKNIQUE FWD MK4 POWER WHEELCHAIR2Cleared 510(K)
- K083249QUICKIE RHYTHM2Cleared 510(K)
- K082722P & F POWER WHEELCHAIR, MODEL HC-500SB2Cleared 510(K)
- K082288HAIDA HD212Cleared 510(K)
- K081964K450 POWERED WHEELCHAIR2Cleared 510(K)
- K073330FREEDOM SCIENCES MOTION CONTROL MODULE (MCM)2Cleared 510(K)
- K080385CRUISER PP5500 CHALLENGER POWERED WHEELCHAIR2Cleared 510(K)
- K080373TACAHE PC1350 POWER WHEELCHAIR2Cleared 510(K)
- K073686C.T.M. POWER CHAIR, MODEL HS-15002Cleared 510(K)
- K073701DANE TECHNOLOGIES WHEELCHAIR MOVER, MODEL WM 20002Cleared 510(K)
- K073134A-SERIES INTEGRAL CONTROLLER, MODEL INT/DL40I2Cleared 510(K)
- K072711COMFORT POWERED WHEELCHAIR, LY-EB 2062Cleared 510(K)
- K072224ZIP'R PC2Cleared 510(K)
- K071650C350 POWERED WHEELCHAIR2Cleared 510(K)
- K072027FORU KV10HB2Cleared 510(K)
- K071005HEARTWAY LIGHTWEIGHT POWER CHAIR, P152Cleared 510(K)
- K071006HEARTWAY ATTENDANT-CONTROLLED POWER CHAIR, TC12Cleared 510(K)
- K070318SKIPPI POWERED WHEELCHAIR FOR CHILDREN2Cleared 510(K)
- K063328IMC HEARTWAY, LLC ELECTRIC POWERED WHEELCHAIR, MODEL ALLURE (HP6)2Cleared 510(K)
- K070655WU'S POWERED WHEELCHAIR, MAMBO 362Cleared 510(K)
- K070501RUIKE 3421 POWERED WHEELCHAIR2Cleared 510(K)
- K070433LERADO, POWER WHEELCHAIR, PB2Cleared 510(K)
- K070489HEARTWAY POWER TILT SEATING SYSTEM POWER CHAIR, MODEL# P16RT2Cleared 510(K)
- K070350P&F POWER WHEELCHAIR, HC-5102Cleared 510(K)
- K063320ELECTRIC POWERED LIFT WHEELCHAIR, MODEL VISION (P13)2Cleared 510(K)
- K063307ELECTRIC POWERED WHEELCHAIR, MODEL - RUMBA SR (4R)2Cleared 510(K)
- K063203ELECTRIC WHEELCHAIR, MODEL RUMBA S (HP4)2Cleared 510(K)
- K063475IMC-HEARTWAY, LLC ELECTRIC WHEELCHAIR, MODEL TIARA (P4AS)2Cleared 510(K)
- K063474ELECTRIC POWERED WHEELCHAIR MODEL-MINI (P14)2Cleared 510(K)
- K062888MIDDLE WHEEL DRIVE POWER CHAIR, CWD012Cleared 510(K)
- K062701QUICKIE RHAPSODY, MWD SERIES II POWER WHEELCHAIR2Cleared 510(K)
- K062483MINI POWER CHAIR, MODEL MN 50002Cleared 510(K)
- K061693FORYOU POWERED WHEELCHAIR, MODEL FC-1002Cleared 510(K)
- K061116MOBILLIFE - MODEL (MOBIL RAIZER 22) - POWER WHEELCHAIR2Cleared 510(K)
- K060531QUICKIE RHYTHM & GROOVE SERIES POWER WHEELCHAIRS W/QUICKIE DELPHI CONTROLS2Cleared 510(K)
- K052534TACAHE2Cleared 510(K)
- K052706A-200 POWERED WHEELCHAIR2Cleared 510(K)
- K052496PRIMECHAIR2Cleared 510(K)
- K052559WU'S POWERED WHEELCHAIR, MAMBO 22Cleared 510(K)
- K052008IMC HEARTWAY - POWER WHEELCHAIR, MODEL HP 72Cleared 510(K)
- K052353Z-CHAIR2Cleared 510(K)
- K042699ABILITY POWER GURNEY2Cleared 510(K)
- K043511SOLEUS POWERED WHEELCHAIR, MODEL FAD-22Cleared 510(K)
- K050264STEALTH PRODUCTS SEATING SYSTEM2Cleared 510(K)
- K050011WU'S POWERED WHEELCHAIR, MAMBO F 1202Cleared 510(K)
- K050010WU'S POWERED WHEELCHAIR, MAMBO 36X2Cleared 510(K)
- K043435QUICKIE INTERCHANGE FWD W/LIFT POWER WHEELCHAIR2Cleared 510(K)
- K042719HOME HEALTH POWER WHEELCHAIR, MODEL HC-2002Cleared 510(K)
- K050087LERADO AVANTICARE POWER WHEELCHAIR, MODEL PW-18002Cleared 510(K)
- K043376HOME HEALTH POWER WHEELCHAIR, MODEL HC-200TR2Cleared 510(K)
- K043069HOVEROUND E100 POWER CHAIR2Cleared 510(K)
- K042920HOVEROUND SE-3 POWERCHAIR2Cleared 510(K)
- K042748GENEMAX POWER WHEELCHAIR, PW32Cleared 510(K)
- K042749GENEMAX POWER WHEELCHAIR, PW42Cleared 510(K)
- K042545HOVEROUND MPV-5 POWERCHAIR2Cleared 510(K)
- K042612JAZZY 6002Cleared 510(K)
- K042535ADVENTURE A102Cleared 510(K)
- K041210POWERED WHEELCHAIR, MODEL B-6002Cleared 510(K)
- K041211POWERED WHEELCHAIR, MODEL C-10002Cleared 510(K)
- K041208POWERED WHEELCHAIR, MODEL B-5002Cleared 510(K)
- K042033HOVEROUND POWER WHEELCHAIR, MODEL HD7002Cleared 510(K)
- K041186CADDY2Cleared 510(K)
- K041346SYNERGY ULTIMATE2Cleared 510(K)
- K041752TEH LIN POWERED WHEELCHAIR, MDG-6012Cleared 510(K)
- K041219ELECTRO2Cleared 510(K)
- K041678KARMA POWER WHEELCHAIR, MODEL KP-252Cleared 510(K)
- K041336PRO WALKER PL-200 POWER WHEELCHAIR2Cleared 510(K)
- K033819INVACARE 3G TARSYS2Cleared 510(K)
- K041341GOLDEN SPYDER, MODEL GS-3002Cleared 510(K)
- K041190A&I POWER WHEELCHAIR, PC-4012Cleared 510(K)
- K040457NOMAD FROM DYNAMIS MOBILITY LTD.2Cleared 510(K)
- K033142POWERED WHEELCHAIR2Cleared 510(K)
- K040320SINON POWER WHEELCHAIR, SN-P4012Cleared 510(K)
- K040319SINON POWER WHEELCHAIR, SN-W4012Cleared 510(K)
- K040020C.T.M. POWER CHAIR, MODEL HS-10002Cleared 510(K)
- K032765STREET2Cleared 510(K)
- K033827UB 1402Cleared 510(K)
- K033206EPW FOLDABLE POWER WHEELCHAIR, EPW-032Cleared 510(K)
- K031711TANGO, MODELS, BP12Cleared 510(K)
- K033100TAIWAN KING STRONG POWERED WHEELCHAIR, TP 012Cleared 510(K)
- K033370POWERED WHEELCHAIR, MODEL FR168W2Cleared 510(K)
- K033097TAIWAN KING STRONG POWERED WHEELCHAIR, TP 022Cleared 510(K)
- K032512Y.E.S POWERED WHEELCHAIR. T1802Cleared 510(K)
- K033263K-TECH 2 POWER TILT SEATING SYSTEM, MODEL K2PT2Cleared 510(K)
- K032441F-10 FOLDING POWER CHAIR2Cleared 510(K)
- K032440F-11 FOLDING POWER CHAIR2Cleared 510(K)
- K031342JASON MARINE ALL TERRAIN ELECTRIC WHEELCHAIR, MODEL SEEKER II2Cleared 510(K)
- K030760COACH 888W2Cleared 510(K)
- K030355COMFORT POWERED WHEELCHAIR, CONQUEROR LY-EB 2022Cleared 510(K)
- K030356COMFORT POWERED WHEELCHAIR, TRAVELLER LY-EB 1032Cleared 510(K)
- K031289QUICKIE FREESTYLE POWER WHEELCHAIR, MODEL G-4242Cleared 510(K)
- K030432IMC-HEARTWAY MODEL HPS ELECTRIC POWERED WHEELCHAIR2Cleared 510(K)
- K024175SUNPEX TECHNOLOGIES MODEL PW2Cleared 510(K)
- K030427HP-3 HD ELECTRIC WHEELCHAIR2Cleared 510(K)
- K030783FRONTIER MODEL X52Cleared 510(K)
- K030707WU'S POWERED WHEELCHAIR, MAMBO 32Cleared 510(K)
- K030709WU'S POWERED WHEELCHAIR, MAMBO 52Cleared 510(K)
- K030250IGLIDE MANUAL ASSIST WHEELCHAIR2Cleared 510(K)
- K022696TEH LIN POWERED WHEELCHAIR, MODEL MDG-2012Cleared 510(K)
- K023148EPW POWERED WHEELCHAIR, GP-2012Cleared 510(K)
- K022697TEH LIN JUPITER POWER CHAIR, MODEL TL-3202Cleared 510(K)
- K023961SCOUT BOSS2Cleared 510(K)
- K023485EXPLORER POWERED WHEELCHAIR2Cleared 510(K)
- K022993HOVEROUND REHAB SEATING SYSTEM FOR POWER WHEELCHAIRS2Cleared 510(K)
- K023426TRX VERTICAL POSITIONER2Cleared 510(K)
- K022652ALPHATRAC, MODEL A 2052Cleared 510(K)
- K023589STORM TDX POWER WHEELCHAIR2Cleared 510(K)
- K022539PHFW-102Cleared 510(K)
- K022194TRAXX ELECTRIC WHEELCHAIR2Cleared 510(K)
- K022704TAILWIND2Cleared 510(K)
- K021617C.T.M. POWER CHAIR, MODEL HS-28002Cleared 510(K)
- K021995ESCAPE CONTROL MODULE2Cleared 510(K)
- K021264TRZ-CG POWER POSITIONING SYSTEM WITH CENTER-OF-GRAVITY SHIFTING POWER TILT, RECLINE, AND POWER ELEVATING SEAT2Cleared 510(K)
- K021592PHFW-102Cleared 510(K)
- K021199PRIMECHAIR2Cleared 510(K)
- K020639TIPOWER TR RIMPOWER AND TIPOWER TRA RIMPOWER2Cleared 510(K)
- K020539TIPOWER POWERDRIVE AND RIMPOWER X & SX2Cleared 510(K)
- K021680INVACARE POWERED WHEELCHAIRS, MODELS M50, M51, M71 & M912Cleared 510(K)
- K021255Y.E.S 10 WHEELCHAIR2Cleared 510(K)
- K021136TEKNIQUE-HOVEROUND POWER WHEEL CHAIR2Cleared 510(K)
- K014127KARMA DISCOVERY, MODEL KP402Cleared 510(K)
- K013361WIN-2 TANGO ELITE NP2Cleared 510(K)
- K013307OMEGATRAC, MODEL Z1052Cleared 510(K)
- K011846BIOTECH POWERED WHEELCHAIR, C650PW2Cleared 510(K)
- K013516INVACARE ELEVATING SEAT OPTION ESS62Cleared 510(K)
- K012846ZIPPY, MODEL I88WA2Cleared 510(K)
- K012909XTERRA GT POWER WHEELCHAIR2Cleared 510(K)
- K012927M71 POWER WHEELCHAIR2Cleared 510(K)
- K012802MP3CF ELECTRIC WHEELCHAIR2Cleared 510(K)
- K011745HP-3, BATTETRY OPERATED, FONT WHEEL DRIVE, POWER WHEELCHAIR2Cleared 510(K)
- K011744HP-5, BATTERY OPERATED, REAR WHEEL DRIVE, POWER WHEELCHAIR2Cleared 510(K)
- K011513MP3U, POWER WHEELCHAIR2Cleared 510(K)
- K011687MP-3C POWER BASE CHAIR, MODEL MP3C2Cleared 510(K)
- K012281TRS-2000 POWER TILT/POWER RECLINE SYSTEM2Cleared 510(K)
- K011993QUANTUM BLAST2Cleared 510(K)
- K010600SUPREMA POWERED WHEELCHAIR2Cleared 510(K)
- K002580PRAIRIE CRUISER2Cleared 510(K)
- K010941THE NIMBLE ROCKET POWERED WHEELCHAIR2Cleared 510(K)
- K011153ALANTE, BATTERY OPERATED POWER WHEELCHAIR2Cleared 510(K)
- K010917POWER TILT AND RECLINE SYSTEM2Cleared 510(K)
- K011227REGAL MOTOTRIZED 3 WHEELED VEHICLE2Cleared 510(K)
- K011006AMYSEAT TILT/RECLINE SEATING2Cleared 510(K)
- K010395E-POWER2Cleared 510(K)
- K010380MP3HD BIG BOY, POWER WHEELCHAIR2Cleared 510(K)
- K011053OPTIMA2Cleared 510(K)
- K010859THE LIBERATOR WHEELCHAIR2Cleared 510(K)
- K010364MCC-MIV ONE 2 ONE SOFTWARE2Cleared 510(K)
- K003449E MOTION WHEELCHAIR DRIVE SYSTEM (POWER-ASSIST FOR MANUAL WHEELCHAIRS)2Cleared 510(K)
- K010075TEKNIQUE2Cleared 510(K)
- K010011TE-2000 POWER TILT/POWER ELEVATING SEAT COMBINATION SYSTEM2Cleared 510(K)
- K993406TRAX, POWERED WHEELCHAIR, MODEL 308686-00-02Cleared 510(K)
- K001491QUICKIE 2 POWER ASSIST WHEELCHAIR2Cleared 510(K)
- K000739EVANTGARDE/ENDEAVOR POWERED WHEELCHAIR2Cleared 510(K)
- K002983C.T.M. POWER CHAIR, MODEL HS-56002Cleared 510(K)
- K001970JET 1 POWERED WHEELCHAIR2Cleared 510(K)
- K000678RAEBBITT/EVOLUTION POWERED WHEELCHAIR2Cleared 510(K)
- K002157RANGER II M6, MODEL IN-888WNL2Cleared 510(K)
- K001923REGENCY POWER WHEELCHAIR, MODEL 7200, 7500 & 78002Cleared 510(K)
- K000796MAGIC MOBILITY 4 X 4 WHEELCHAIR2Cleared 510(K)
- K000204WIN-1 TANGO2Cleared 510(K)
- K001777MODEL CGS TILT SEATING SYSTEM FOR POWER WHEELCHAIRS2Cleared 510(K)
- K992828E-2000 POWER ELEVATING SEAT SYSTEM, MODELS ARD-ESTORM, ARD-EP320, ARD-ELANCER2Cleared 510(K)
- K992804T-2000-POWER TILT SEATING SYSTEM, MODELS ARD-TSTORM, ARD-TP-320, ARD-TG424, ARD-TS525, ARD-TJAZZY, ARD-TLANCER2Cleared 510(K)
- K994241TRX-CG POWER TILT AND RECLINE SYSTEM2Cleared 510(K)
- K994107AMYSYSTEMS PTS50-50 DEGREE POWER TILT SYSTEM FOR MID-WHEEL OR FRONT-WHEEL DRIVE POWER WHEELCHAIRS.2Cleared 510(K)
- K994072AMYSYSTEMS PTS50CG 50 DEGREE WEIGHT SHIFT POWER TILT SYSTEM2Cleared 510(K)
- K993443RTD ARM ASSISTIVE ROBOTIC DEVICE2Cleared 510(K)
- K993413STORM SERIES, POWER 9000 SERIES AND POWER TIGER WITH GYROSCOPE CONTROL2Cleared 510(K)
- K993160OMEGA TRAC, MODEL Z1002Cleared 510(K)
- K993032MODIFICATION TO MP-3 POWER BASE CHAIR2Cleared 510(K)
- K991954THE BRUNO POWERBASE, MODEL PSB-22002Cleared 510(K)
- K992628FIRSTCLASS POWER TILT AND RECLINE SEAT SYSTEM, MODEL S4002Cleared 510(K)
- K992627FIRST CLASS POWER RECLINE SEATING SYSTEM, MODEL S5002Cleared 510(K)
- K992619AMIGO MODEL 680000 (AMIGO EXCITE F 350)2Cleared 510(K)
- K983808ZIPPY2Cleared 510(K)
- K991658PERMOBIL POWERED WHEELCHAIR 12802Cleared 510(K)
- K991090PEACHTREE PROPORTIONAL HEAD CONTROL UNIT (PHC-3)2Cleared 510(K)
- K991119TILT/RECLINER FOR POWER WHEELCHAIRS, MODEL 2G2Cleared 510(K)
- K982724THERADYNE ROVER POWERED WHEELCHAIR2Cleared 510(K)
- K983497OVERLANDER PEV 20002Cleared 510(K)
- K991168ARROW FWD POWER WHEELCHAIR2Cleared 510(K)
- K990484INDEPENDENCE 3242Cleared 510(K)
- K990122INDEPENDENCE 6242Cleared 510(K)
- K990544TRX-CG POWER TILT AND RECLINE SYSTEM2Cleared 510(K)
- K982750CORSAIRE2Cleared 510(K)
- K983066FIRSTCLASS POWER TILT SEAT SYSTEM, MODEL S3002Cleared 510(K)
- K983677QUICKIE G SERIES, MODEL G-4242Cleared 510(K)
- K983520BREATH CONTROL (BREATH ACTUATOR), SENSITOUCH BREATH CONTROL, HEAD ARRAY (SWITCH HEAD CONTROL), TRI-SWITCH HEAD ARRAY, HD2Cleared 510(K)
- K982815ALPHATRAC, MODEL A2002Cleared 510(K)
- K981462QUICKIE P100 SERIES, QUICKIE P200 SERIES, QUICKIE P300 SERIES, MODELS P100,P110,P120,P190,P190R,P500,P200,P210,P320,P3002Cleared 510(K)
- K982064ACTION STORM RANGER II, ACTION STORM POWER 90002Cleared 510(K)
- K982158SCOUT2Cleared 510(K)
- K982066MP-3 POWER BASE CHAIR2Cleared 510(K)
- K981837TRX-CG CENTER-OF-GRAVITY SHIFTING POWER TILT AND RECLINE SYSTEMS2Cleared 510(K)
- K972851ZIPPY2Cleared 510(K)
- K972230QUICKIE P90 SERIES2Cleared 510(K)
- K972370RASCAL POWER CHAIR2Cleared 510(K)
- K972564TILT MASTER CG SYSTEM (CENTER OF GRAVITY), TILT-N-SPACE-SEAT2Cleared 510(K)
- K972147PEACHTREE PROPORTIONAL HEAD CONTROL UNIT (PHC-2)2Cleared 510(K)
- K972563LIFT MASTER2Cleared 510(K)
- K970575ELECTRO-LITE ELITE POWERED WHEELCHAIR2Cleared 510(K)
- K970094MODEL DX MICRO COMPUTER CONTROL2Cleared 510(K)
- K970743BCW POWER ADVANTAGE WHEELCHAIR2Cleared 510(K)
- K960951PERMOBIL CHAIRMAN L/CS 82Cleared 510(K)
- K963385QUICKIE POWER WHEELCHAIRS P200 SERIES2Cleared 510(K)
- K963382QUICKIE P100 SERIES2Cleared 510(K)
- K963381QUICKIE P300 SERIES2Cleared 510(K)
- K970164ROLL AID2Cleared 510(K)
- K970521TRX POWER TILT AND RECLINE SYSTEM2Cleared 510(K)
- K962565POWERED WHEELCHAIR2Cleared 510(K)
- K963808CHOICE POWERED WHEELCHAIR2Cleared 510(K)
- K955547CHIPS STANDUP WHEELCHAIR2Cleared 510(K)
- K955548CHIPS POWERED WHEELCHAIR2Cleared 510(K)
- K954427HELPING HAND2Cleared 510(K)
- K950025SELF PROPELLED ROBOTIC WHEEL (SPRW)2Cleared 510(K)
- K961744TK40 - TILTMASTER2Cleared 510(K)
- K955240OMEGATRAC BY TEFTEC2Cleared 510(K)
- K954131HOVEROUND POWER WHEELCHAIR OR HVR-200 BY HOVEROUND2Cleared 510(K)
- K945936JAZZY2Cleared 510(K)
- K952675ORTHOFAB WHEELCHAIR2Cleared 510(K)
- K954135POWERCHAIR2Cleared 510(K)
- K954044SIDEKICK POWER WHEELCHAIR2Cleared 510(K)
- K945047BCW 600 POWER WHEELCHAIR2Cleared 510(K)
- K950724MODEL INT/DL40I MICRO COMPUTER CONTROLLER FOR POWER WHEELCHAIRS2Cleared 510(K)
- K940920ROAD SAVAGE2Cleared 510(K)
- K940851RED PACK MANLUAL POWER WHEELCHAIR CONVERSION KIT2Cleared 510(K)
- K935750GERONIMO2Cleared 510(K)
- K935751GERONIMO PR2Cleared 510(K)
- K935749ROAD WARRIOR2Cleared 510(K)
- K944423POWER RECLINER2Cleared 510(K)
- K943789POWER WHEELCHAIR CONVERSION KIT2Cleared 510(K)
- K942075VECTOR POWER WHEELCHAIR2Cleared 510(K)
- K940972MODEL MCC - MKIV MICRO COMPUTER CONTROLS2Cleared 510(K)
- K935201QUADTRAX2Cleared 510(K)
- K930742PEGASUS PROACTIVE WHEELCHAIR CUSHION2Cleared 510(K)
- K933662MERITS WHEELCHAIR2Cleared 510(K)
- K934232COMMUTER (MANUAL/POWER WHEELCLHAIR)2Cleared 510(K)
- K925724M100 POWERED WHEELCHAIR2Cleared 510(K)
- K940051ACTION STORM POWER WHEELCHAIR2Cleared 510(K)
- K935410HOVEROUND MPV2Cleared 510(K)
- K935317ALPHA TALKER2Cleared 510(K)
- K933854770 POWER BASE2Cleared 510(K)
- K933858730 POWER BASE2Cleared 510(K)
- K933856A921 12 VOLT POWER SOCKET2Cleared 510(K)
- K933855S490 SEATING SYSTEM2Cleared 510(K)
- K933864720 POWER BASE2Cleared 510(K)
- K933853A901 TILT IN SPACE2Cleared 510(K)
- K933863S500 SEATING SYSTEM2Cleared 510(K)
- K933861S860 SEATING SYSTEM2Cleared 510(K)
- K933860S480 SEATING SYSTEM2Cleared 510(K)
- K933859SC930 SEAT CONTROLLER2Cleared 510(K)
- K933207WALKERTALKER2Cleared 510(K)
- K932786UCS 1000(TM) WITH TONGUETOUCH KEYPAD WHEELCHAIR2Cleared 510(K)
- K932597FORTRESS C-300 MICROPROCESSOR CONTROLLER2Cleared 510(K)
- K932329HOVEROUND POWER CHAIR2Cleared 510(K)
- K930088FORTRESS C-500 MICROPROCESSOR CONTROLLER2Cleared 510(K)
- K925865KID POWER2Cleared 510(K)
- K924278QUICKIE P2002Cleared 510(K)
- K930676ACTION TIGER POWERED WHEELCHAIR2Cleared 510(K)
- K923362REDUCED SHEAR OWR RECLINE SYSTEM2Cleared 510(K)
- K923365TILT/REDUCED SHEAR SEMI-RECLINE SEATING SYSTEM2Cleared 510(K)
- K923363ADJUSTABLE SLIDING BACK POWER RECLINE SYSTEM2Cleared 510(K)
- K921070FORTRESS 760-N 4 WHEEL POWER WHEELCHAIR2Cleared 510(K)
- K920325RANGEROLLER (MODIFIED)2Cleared 510(K)
- K920180QUICKIE P1002Cleared 510(K)
- K915609ULTRA R-11 CRUISER2Cleared 510(K)
- K914938MICRO COMPUTER CONTROLS, MODEL# MCC-MK-RII-X2Cleared 510(K)
- K914737ASL MODEL #1042Cleared 510(K)
- K915152RANGEROLLER2Cleared 510(K)
- K914738ASL MODEL 1012Cleared 510(K)
- K913645SPECIALTY CONTROLS INTERFACE2Cleared 510(K)
- K914739ASL MODEL #1022Cleared 510(K)
- K914740ASL MODEL #1032Cleared 510(K)
- K914091POWER RECLINER WHEELCHAIR2Cleared 510(K)
- K913901FREEDOM WHEELS AZ 1002Cleared 510(K)
- K905292SYSTEM 502Cleared 510(K)
- K904246SYSTEM 70 AND 1002Cleared 510(K)
- K911986RAMP RAT2Cleared 510(K)
- K911151POWER WHEELCHAIR - TILT & RECLINE SEATING SYSTEM2Cleared 510(K)
- K904650WHEELCHAIR CONVERSION KIT2Cleared 510(K)
- K910749FORTRESS MODEL 760-V 4 WHEEL POWER WHEELCHAIR2Cleared 510(K)
- K910753FORTRESS MODEL SPIRIT 4-WHEEL POWER WHEELCHAIR2Cleared 510(K)
- K911152QUAD-LINK RETRACTABLE MOUNT2Cleared 510(K)
- K905293SYSTEM 90 AND 952Cleared 510(K)
- K904958TEMPEST ELECTRIC WHEELCHAIR2Cleared 510(K)
- K904818XCALIBER2Cleared 510(K)
- K904862HANDI-TRACTION2Cleared 510(K)
- K904817MAGNUM2Cleared 510(K)
- K901707FORTRESS COMMUTER FT (FOLDING TRANSPORT)2Cleared 510(K)
- K901708FORTRESS COMMUTER RT (RIGID TRANSPORT)2Cleared 510(K)
- K901210BOUNDER VA POWER WHEELCHAIR2Cleared 510(K)
- K900514JYROCHAIR POWER WHEELCHAIR2Cleared 510(K)
- K900565INVACARE POWER 9000 SERIES WHEELCHAIR2Cleared 510(K)
- K900330QUICKIE P300 WHEELCHAIR2Cleared 510(K)
- K900040FORTRESS SPIRIT POWER WHEELCHAIR2Cleared 510(K)
- K900039FORTRESS VICTORY POWER WHEELCHAIR2Cleared 510(K)
- K900038FORTRESS 760FS POWER WHEELCHAIR2Cleared 510(K)
- K900037FORTRESS 755FS PEDIATRIC WHEELCHAIR2Cleared 510(K)
- K895596FORTRESS 1000FS ADD-ON POWER UNIT2Cleared 510(K)
- K895595FORTRESS 655FS POWER WHEELCHAIR2Cleared 510(K)
- K894346D88VS WHEELCHAIR POWER SYSTEM2Cleared 510(K)
- K894344ELECTRO-LITE POWER WHEELCHAIR2Cleared 510(K)
- K893428ALPHA SHOPPER2Cleared 510(K)
- K885261ARROW MICRO COMPUTER CONTROL SWITCH & ENVIRON. SYS2Cleared 510(K)
- K885212ARROW MICRO COMPUTER CONTROL2Cleared 510(K)
- K890723LANCER - MODULAR POWER BASE2Cleared 510(K)
- K890490RUG BUG WHEEL CHAIR2Cleared 510(K)
- K8851031600 LIGHT TOUCH CONTROL2Cleared 510(K)
- K884812KARMA-RS, KARMA-FS WHEELCHAIRS2Cleared 510(K)
- K880361MODEL #1552 ATTENDANT CONTROL OPTION2Cleared 510(K)
- K880363MODEL #1554 PNEUMATIC SWITCH2Cleared 510(K)
- K880364MODEL #1555 REMOTE JOYSTICK2Cleared 510(K)
- K880365MODEL #1556 HEAVY-DUTY JOYSTICK2Cleared 510(K)
- K880360MODEL #1551 SWITCH CONTROL INTERFACE UNIT2Cleared 510(K)
- K880362MODEL #1553 RECLINER INTERFACE2Cleared 510(K)
- K8836784007 MODEL RECLINER CONTROLLER2Cleared 510(K)
- K883674MANUAL SWING ARM2Cleared 510(K)
- K883673POWER MECHANICAL RECLINER2Cleared 510(K)
- K883672PARALYZED VETERANS OF AMERICA POWER RECLINER2Cleared 510(K)
- K883671805 POWER CHAIR CONVERSION SYSTEM2Cleared 510(K)
- K883339CLIPPER POWER DRIVE WHEELCHAIR2Cleared 510(K)
- K874417TASH PILOT SYSTEM2Cleared 510(K)
- K881463MULTIMODE(TM) POWER MODULE SYSTEM2Cleared 510(K)
- K881464MULTIMODE(TM) INTERFACE SYS. FOR EVEREST & JENNING2Cleared 510(K)
- K881462UNIMODE(TM) POWER MODULE SYSTEM2Cleared 510(K)
- K881461MULTIMODE(TM) INTERFACE SYSTEM FOR MEYRA WHEELCH.2Cleared 510(K)
- K874739ELECTRIC MOBILITY'S SPARKY2Cleared 510(K)
- K880707WHEEL-CHAIR W/MOTOR DRIVE2Cleared 510(K)
- K880423TARGA (WHEELCHAIR)2Cleared 510(K)
- K874448NOVA TRANSFER SYSTEM, MODEL XXX2Cleared 510(K)
- K873895HOT WHEELS2Cleared 510(K)
- K870532GALAXY POWERED WHEELCHAIR2Cleared 510(K)
- K870297DAKOTA MODEL 102C WHEELCHAIR2Cleared 510(K)
- K870224PERMOBIL MAXIOR2Cleared 510(K)
- K870228PERMOBIL HEXIOR2Cleared 510(K)
- K870227PERMOBIL SUPERIOR2Cleared 510(K)
- K870226PERMOBIL MINIOR2Cleared 510(K)
- K870225PERMOBIL EXTERIOR2Cleared 510(K)
- K865003A-BEC 462Cleared 510(K)
- K865004A-BEC 40 POWER WHEELCHAIR2Cleared 510(K)
- K865001A-BEC FIREBALL 402Cleared 510(K)
- K865009A-BEC 472Cleared 510(K)
- K865008A-BEC 172Cleared 510(K)
- K865007A-BEC 152Cleared 510(K)
- K865006A-BEC 142Cleared 510(K)
- K865005A-BEC 412Cleared 510(K)
- K864791POIRIER POWERED WHEELCHAIR2Cleared 510(K)
- K865072ARROW XT POWERED WHEELCHAIR2Cleared 510(K)
- K863233STC 909ZX POWER BASE2Cleared 510(K)
- K863407GRAF CORELLO, POWERED WHEELCHAIR2Cleared 510(K)
- K863250CHILD'S ROLLS POWERED WHEELCHAIR2Cleared 510(K)
- K862405RUNAROUND2Cleared 510(K)
- K861729SPRINT (POWER DRIVE WHEELCHAIR)2Cleared 510(K)
- K855086KATALAVOX VOICE-ACTIVATED SWITCHING DEVICE2Cleared 510(K)
- K854164CRUISER2Cleared 510(K)
- K854153MARATHON POWER DRIVE-WHEELCHAIR2Cleared 510(K)
- K854051MODULAR POWER BASE2Cleared 510(K)
- K853649POWER DRIVE WHEELCHAIR2Cleared 510(K)
- K853595VESSA TREKKA2Cleared 510(K)
- K852381FALCON (POWERED WHEELCHAIR)2Cleared 510(K)
- K853593VESSA TRAVVLA2Cleared 510(K)
- K853594VESSA FLIVVA2Cleared 510(K)
- K852813RANGER(II)2Cleared 510(K)
- K852809JAGUAR2Cleared 510(K)
- K852810RABBIT2Cleared 510(K)
- K852811RANGER-X2Cleared 510(K)
- K852379SUNBIRD (POWERED WHEELCHAIR)2Cleared 510(K)
- K852015JYROCHAIR, MODEL SK-H2Cleared 510(K)
- K851381POWER DRIVE WHEELCHAIR-VARIOUS2Cleared 510(K)
- K851261ALEXIS2Cleared 510(K)
- K850876LIGTVOET L80.2 LIGHTFOOT L80.2 POWER WHEELCHAIR2Cleared 510(K)
- K844847MOBILCHAIR 360 ELECTRIC-POWERED CHAIR2Cleared 510(K)
- K841921ALPHA PLUS 12Cleared 510(K)
- K841912ALPHA 4 X 42Cleared 510(K)
- K841542OMNIDIRECTIONAL POWERED WHEEL CHAIR2Cleared 510(K)
- K840624COMBI2Cleared 510(K)
- K840640POSITELEC WHEELCHAIR2Cleared 510(K)
- K834552PREMIER2Cleared 510(K)
- K832745OC3 FLYER2Cleared 510(K)
- K832325BASE ONLY, POWER WHEELCHAIR2Cleared 510(K)
- K823085BERKELEY CHAIR2Cleared 510(K)
- K823175SIDEWINDER OMNI WHEELCHAIR DIRECT/POWER2Cleared 510(K)
- K823117HITCH HIKER2Cleared 510(K)
- K813104POWER DRIVE WHEELCR2Cleared 510(K)
- K811656POWERED WHEELCHAIR2Cleared 510(K)
- K802986POWERED WHEELCHAIR2Cleared 510(K)
- K800209BOOTS - OUTDOOR CARRIER FOR THE AMIGO2Cleared 510(K)
- K791408MAINSTREAM ELEVATING WHEEL CHAIR2Cleared 510(K)
- K790858PERMOBIL EXTERIOR2Cleared 510(K)
- K790859PERMOBIL SUPERIOR2Cleared 510(K)
- K780402POWER STRIDER2Cleared 510(K)
- 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
BOUNDER 300 Power Wheelchair, BOUNDER Plus 300 Power Wheelchair, BOUNDER 450 Power Wheelchair, BIG BOUNDER 600 Power Wheelchair, BIG BOUNDER 1000 Power Wheelchair
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K193599
- 510(k) Type
- Traditional
- Applicant
- 21st Century Scientific, Inc.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 9/3/2020
- Days to Decision
- 255 days
- Submission Type
- Summary