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
- K250027Powered Mobility Scooter2Cleared 510(K)
- K242982Mobility Scooter (MS160A)2Cleared 510(K)
- K242714Mobility Scooter (S-01); Mobility Scooter (S-02)2Cleared 510(K)
- K240590Electrical Scooter, WT-T4SU2Cleared 510(K)
- K242760WHILL Model R2Cleared 510(K)
- K242139Mobility Scooter (YL-09B, YL-07)2Cleared 510(K)
- K242628Scooter (PS30)2Cleared 510(K)
- K242387Mobility Scooter (N3473)2Cleared 510(K)
- K240990Mobility Scooter2Cleared 510(K)
- K232692Powered Mobility Scooter (Models: PMS101, GUT112, PMS103, GUT140)2Cleared 510(K)
- K240272Electric Scooter (M2085, S2091)2Cleared 510(K)
- K240008Mobility Scooter (W3331)2Cleared 510(K)
- K240012Mobility Scooter (W3431)2Cleared 510(K)
- K234098Mobility Scooter (C4+)2Cleared 510(K)
- K231472Mobility Scooter (S1 SPORT, S1 PLUS, MAX SPORT)2Cleared 510(K)
- K231428Mobility Scooter (Models: W3431D)2Cleared 510(K)
- K230001Electric Scooter (Model: M2020)2Cleared 510(K)
- K222703ATTO Mobility Scooter (ATTO);ATTO Mobility Scooter (ATTO SPORT);ATTO Mobility Scooter (ATTO SPORT MAX)2Cleared 510(K)
- K230615Electric Scooter (Model: S3312)2Cleared 510(K)
- K222729Electrical Scooter, WT-T4QP22Cleared 510(K)
- K222507Mobility Scooter (Models: W3431Q, W3431R)2Cleared 510(K)
- K223492eFOLDi Scooter, Lite2Cleared 510(K)
- K222711HS186B Scooter2Cleared 510(K)
- K222495Mobility Scooter, Model: W3331F2Cleared 510(K)
- K220227Auto Folding Scooter, S21F2Cleared 510(K)
- K212090Electric Scooter2Cleared 510(K)
- K220206Mobility Scooter2Cleared 510(K)
- K220207Mobility Scooter, Model W34682Cleared 510(K)
- K191356i3 Foldable Mobility Scooter2Cleared 510(K)
- K201196Scooter (Model: FDB01)2Cleared 510(K)
- K190737Solax Electric Scooter (Models: S204311M, S204161, S204143)2Cleared 510(K)
- K192190Solax Electric Scooter2Cleared 510(K)
- K202549Solax Electric Scooter (Model: S202261B)2Cleared 510(K)
- K191897Solax Electric Scooter (Models: S3023, S3024, S3025, S3026)2Cleared 510(K)
- K192308Wu's Electrical Scooter2Cleared 510(K)
- K192885C.T.M. Mobility Scooter HS-2682Cleared 510(K)
- K182631SupaScoota Motorized vehicle - Spartan (Sumo)/ Spartan SP (Sumo SP)2Cleared 510(K)
- K182471Scooter2Cleared 510(K)
- K182411Scooter, Model: R-1002Cleared 510(K)
- K181344C.T.M Mobility Scooter2Cleared 510(K)
- K172440Solax Electric Scooter, Models: S302121, S302131, S302141, S3021512Cleared 510(K)
- K172409Lite2Cleared 510(K)
- K170634Quingo Classic Power Scooter S1301, Quingo Flyte Power Scooter S551, Quingo Toura Power Scooter 53502Cleared 510(K)
- K171256Quingo Flyte Mobility Scooter2Cleared 510(K)
- K162952C.T.M. Mobility Scooter2Cleared 510(K)
- K163201KYMCO EQ10D Scooter2Cleared 510(K)
- K160835Titan 3W2Cleared 510(K)
- K160909ATTO Mobility Scooter2Cleared 510(K)
- K151656HEARTWAY Power Mobility Scooter2Cleared 510(K)
- K150998HEARTWAY Power Mobility Scooter2Cleared 510(K)
- K150987HEARTWAY Power Mobility Scooter, BRIO S192Cleared 510(K)
- K143557SupaScoota Motorized vehicle2Cleared 510(K)
- K151944Luggie Super2Cleared 510(K)
- K150086Titan2Cleared 510(K)
- K142912Merits Yoga Power Scooter, S5422Cleared 510(K)
- K142162MERITS TRANSFORMER POWER SCOOTER, S9412Cleared 510(K)
- K133187FREERIDER FR1, models FR1-13, FR1-15, FR1-172Cleared 510(K)
- K132855HEARTWAY POWER MOBILITY SCOOTER2Cleared 510(K)
- K131302SOLAX2Cleared 510(K)
- K130940KYMCO EQ20C SCOOTER2Cleared 510(K)
- K122749PRESTIGE-MOBIE2Cleared 510(K)
- K110165FREERIDER MODEL LUGGIE MODEL 168-4IT2Cleared 510(K)
- K103771LOTUS BLAKE ESTEEM SCOOTER2Cleared 510(K)
- K110567C.T.M. MOBILITY SCOOTER HS515(3W)2Cleared 510(K)
- K110395C.T.M. MOBILITY SCOOTER - MODEL HS 1182Cleared 510(K)
- K102304BREEZE C MODEL C (3W), BREEZE C (4W)2Cleared 510(K)
- K102361ZIP'R4/ ZIP'R4 XTRA SCOOTER2Cleared 510(K)
- K102358ZIP'R3/ ZIP'R3 XTRA SCOOTER2Cleared 510(K)
- K101507AMIGO CLASSIC FD2Cleared 510(K)
- K101143HEARTWAY POWER MOBILITY SCOOTER, S112Cleared 510(K)
- K101142HEARTWAY LIGHTWEIGHT POWER MOBILITY SCOOTER, S342Cleared 510(K)
- K092650HEARTWAY POWER MOBILITY SCOOTER, S122Cleared 510(K)
- K092154HEARTWAY POWER MOBILITY SCOOTER, S92Cleared 510(K)
- K092155HEARTWAY POWER MOBILITY SCOOTER, S82Cleared 510(K)
- K092088VICTORY XL 130 FOUR WHEEL SCOOTER, MODEL SC7132Cleared 510(K)
- K091418C.T.M. MOBILITY SCOOTER, MODEL HS-628, INVACARE ORION2Cleared 510(K)
- K090735C.T.M. MOBILITY SCOOTER, HS-5282Cleared 510(K)
- K091212WU'S 3 WHEELED ELECTRICAL SCOOTER, WT-T3H2Cleared 510(K)
- K090966AMIGO CATEGORY III FULL-SIZED REGULAR DUTY 3 WHEEL (310000) AND AMIGO CATEGORY V HEAVY DUTY 3 WHEEL (650000)2Cleared 510(K)
- K091113MAXIMA V, THREE WHEEL SCOOTER, MODEL SC900V MAXIMA V, FOUR WHEEL SCOOTER, MODEL SC940V2Cleared 510(K)
- K090805V10, THREE WHEEL SCOOTER, MODEL SC610V, V10, THREE WHEEL SCOOTER, MODEL SC610VPS, V10, FOUR WHEEL SCOOTER, MODEL SC7102Cleared 510(K)
- K090524GO GO ELITE TRAVELER V THREE WHEEL SCOOTER, MODEL SC40EV2Cleared 510(K)
- K083303LANDLEX, MODEL: 402X2Cleared 510(K)
- K082963WU'S 4-WHEELED NEO SCOOTER, WT-M3A2Cleared 510(K)
- K082901KYMCO FORU, MODEL EQ202Cleared 510(K)
- K082900KYMCO FORU, MODEL EQ102Cleared 510(K)
- K081980KYMCO FORU, MODEL EQ352Cleared 510(K)
- K081133KYMCO FORU, MODEL EQ402Cleared 510(K)
- K080242HEARTWAY POWER MOBILITY SCOOTER, PF72Cleared 510(K)
- K080288TRAVEL PAL FOUR WHEEL SCOOTER, MODEL MM1142Cleared 510(K)
- K073044HEARTWAY POWER MOBILITY SCOOTER, MODEL PT72Cleared 510(K)
- K072712COMFORT ELECTRIC SCOOTER, LY-EW4082Cleared 510(K)
- K072630FORU, MODEL EQ302Cleared 510(K)
- K072337WU'S 4-WHEELED NEO SCOOTER, MODEL WT-M4A2Cleared 510(K)
- K072165VICTORY THREE WHEEL SCOOTER, MODEL: SC6102Cleared 510(K)
- K072104HEARTWAY POWER MOBILITY SCOOTER, PF62Cleared 510(K)
- K071949VICTORY, 4 WHEEL SCOOTER / MODEL, # SC17402Cleared 510(K)
- K071282MODEL SEGAEGO 4D SCOOTER2Cleared 510(K)
- K071284MODEL SEGAEGO 3D SCOOTER2Cleared 510(K)
- K071007HEARTWAY LIGHTWEIGHT POWER MOBILITY SCOOTER, S332Cleared 510(K)
- K070817LERADOTECH SCOOTER, MODEL SB2Cleared 510(K)
- K070802LERADOTECH, MODEL SC2Cleared 510(K)
- K070602C.T.M. MOBILITY SCOOTER# HS-2652Cleared 510(K)
- K070493HEARTWAY POWER TILT SEATING SYSTEM POWER CHAIR, P17RT2Cleared 510(K)
- K070603C.T.M. MOBILITTY SCOOTER # HS-2952Cleared 510(K)
- K062646RUIKE, MODEL 34112Cleared 510(K)
- K070025C.T.M. MOBILITY SCOOTER, MODEL HS-3102Cleared 510(K)
- K063196LANDLEX, MODEL S403X2Cleared 510(K)
- K062645RUIKE, MODEL 34312Cleared 510(K)
- K062676RUIKE, MODEL 33312Cleared 510(K)
- K063030COMFORT SCOOTER MODEL LY-EW4062Cleared 510(K)
- K063389GO GO ELITE TRAVELLER PLUS 4 WHEEL SCOOTER, MODEL SC542Cleared 510(K)
- K063162GOLDEN LITEWAY2Cleared 510(K)
- K063032COMFORT SCOOTER, MODEL LY-EW4152Cleared 510(K)
- K062790WU'S 3-WHEELED NEO SCOOTER, MODEL WT-T3E2Cleared 510(K)
- K062160GO GO MINI, MODEL SC302Cleared 510(K)
- K061912FUSION2Cleared 510(K)
- K060697TRAVEL PAL (MM-111B) /MEGA MOTION2Cleared 510(K)
- K060068AVANTICARE, MODEL SA40212Cleared 510(K)
- K052204THE ELITE - ULTRA-LIGHT, COMPACT PORTABLE SCOOTER2Cleared 510(K)
- K060042LANDLEX, MODEL P100X2Cleared 510(K)
- K051028BREEZE2Cleared 510(K)
- K052558VCS, MODEL S4T2Cleared 510(K)
- K052673KING I POWERED SCOOTER, MODEL CTL-112Cleared 510(K)
- K052486PROASIA, MODEL L45012Cleared 510(K)
- K052378PROASIA, MODEL L34022Cleared 510(K)
- K051130VCS S3Y2Cleared 510(K)
- K051473LEARDO, AVANTICARE ELECTRICAL SCOOTERSM30212Cleared 510(K)
- K051131VCS S3T2Cleared 510(K)
- K051538AVANTICARE, MODEL SA40222Cleared 510(K)
- K050793LANDLEX MODEL S400X2Cleared 510(K)
- K050507SMARTECH, MODEL HOLI I2Cleared 510(K)
- K051116MODEL TL-560 POWER SCOOTER2Cleared 510(K)
- K051118MODEL TL-360 POWER SCOOTER2Cleared 510(K)
- K050792LANDLEX, MODEL S300X2Cleared 510(K)
- K050042WU'S 4-WHEELED NEO SCOOTER, WT-XL42Cleared 510(K)
- K043326BEWELL, MODEL SC 202Cleared 510(K)
- K042104AMERICAN BANTEX, MODEL MS 32Cleared 510(K)
- K042764MEDLINE STRIDER MIDI 42Cleared 510(K)
- K042763MODIFICATION TO MEDLINE STRIDER MIDI 32Cleared 510(K)
- K042012TEH LIN POWER SCOOTER, MODEL TL-8222Cleared 510(K)
- K042011POWER SCOOTER, MODEL TL08212Cleared 510(K)
- K042010POWER SCOOTER, MODEL TL-6882Cleared 510(K)
- K041677KARMA SCOOTER, MODEL KS-747.22Cleared 510(K)
- K040754AMERICAN BANTEX MS 4 MINI SCOOTER2Cleared 510(K)
- K041187A&I SCOOTER, SC-3012Cleared 510(K)
- K041193A&I SCOOTER, SC-4022Cleared 510(K)
- K041055MEDLINE STRIDER MAXI 42Cleared 510(K)
- K041054MEDLINE STRIDER MAXI 32Cleared 510(K)
- K041053MEDLINE STRIDER MICRO 32Cleared 510(K)
- K040838MEDLINE STRIDER MINI 42Cleared 510(K)
- K040818MEDLINE STRIDER MINI 32Cleared 510(K)
- K041025BUZZAROUND, VEHICLE, MOTORIZED 3-WHEELED2Cleared 510(K)
- K040968WU'S 4-WHEELED NEO SCOOTER, MODEL WT-T4D2Cleared 510(K)
- K033116OPTI-RIDER DELUXE2Cleared 510(K)
- K040097MEDLINE STRIDER MIDI 32Cleared 510(K)
- K032446MEDLINE STRIDER, MODELS MIDI 3 AND MIDI 42Cleared 510(K)
- K033019SUNPEX TECHNOLOGIES MODEL SE032Cleared 510(K)
- K033240BE-MOBILE 3-WHEELED ELECTRIC SCOOTER, MODEL DK S2002Cleared 510(K)
- K033220BE-MOBILE 4-WHEELED ELECTRIC SCOOTER, MODEL DK S2802Cleared 510(K)
- K032643JUSTWIN SCOOTER, JS-30132Cleared 510(K)
- K032645JUSTWIN SCOOTER, JS-30142Cleared 510(K)
- K032488WU'S 3-WHEELED NEO SCOOTER, WT-T3D2Cleared 510(K)
- K032879NAVIGATOR I2Cleared 510(K)
- K033239BE-MOBILE 4-WHEELED ELECTRIC SCOOTER, MODEL DK S5002Cleared 510(K)
- K033219BE-MOBILE 4-WHEELED ELECTRIC SCOOTER, MODEL DK S6002Cleared 510(K)
- K033204ESG 4-WHEEL SCOOTER, ESG-032Cleared 510(K)
- K032617WU'S 4-WHEELED SCOOTER, WT-L4JR2Cleared 510(K)
- K033241BE-MOBILE 3-WHEELED ELECTRIC SCOOTER, MODEL DK S3202Cleared 510(K)
- K033032WU'S 3-WHEELED NEO SCOOTER, MODEL WT-M3JR2Cleared 510(K)
- K032919C.T.M. MOBILITY SCOOTER, MODEL HS-2502Cleared 510(K)
- K032918C.T.M. MOBILITY SCOOTER, MODEL HS-2352Cleared 510(K)
- K030757COACH 777-42Cleared 510(K)
- K030756COACH 777-32Cleared 510(K)
- K032489WU'S 4-WHEELED NEO SCOOTER, WT-M4JR2Cleared 510(K)
- K032277JUSTWIN SCOOTER, MODEL JS-4012Cleared 510(K)
- K031897PF-2 BATTERY OPERATED ELECTRIC FOUR WHEEL POWER SCOOTER2Cleared 510(K)
- K031315TMC ELECTRICAL SCOOTER, EASY 3212Cleared 510(K)
- K031314TMC ELECTRICAL SCOOTER, EASY 4112Cleared 510(K)
- K031313TMC ELECTRICAL SCOOTER, EASY 4052Cleared 510(K)
- K031309KUANN DAH, COOL TANK MOTORIZED SCOOTER, KS4L3202Cleared 510(K)
- K030758COACH 8882Cleared 510(K)
- K031272C.T.M. MOBILITY SCOOTER, MODEL HS-1202Cleared 510(K)
- K030759LITTLE COACH2Cleared 510(K)
- K024325JI-EE ELECTRIC SCOOTER, ESTHETE ES 12Cleared 510(K)
- K024329JI-EE ELECTRIC SCOOTER, ELEGANCE ES 32Cleared 510(K)
- K030814INVACARE ADVENTURE SERIES SCOOTERS, MODELS ADVENTURE SX-3 & LX-32Cleared 510(K)
- K030387C.T.M. MOBILITY SCOOTER, MODEL HS-8902Cleared 510(K)
- K023166WU'S 3-WHEELED NEO SCOOTER, WT-M42Cleared 510(K)
- K023168WU'S 3-WHEELED NEO SCOOTER, WT-T3B2Cleared 510(K)
- K023040WU'S 3-WHEELED NEO SCOOTER, WT-L32Cleared 510(K)
- K023581COMFORT AGILE SCOOTER, LY-EW3032Cleared 510(K)
- K022698SCOOTER MARS SERIES, MODEL TL-5882Cleared 510(K)
- K022518J.P. 3-WHEELED SCOOTER, ES-350 CITYBUG II/ RABBIT2Cleared 510(K)
- K021925SUNPEX TECHNOLOGIES MODEL SE 012Cleared 510(K)
- K022369COMFORT WINDJOY SCOOTER, MODEL LY-EW3022Cleared 510(K)
- K021910COMFORT DREAMRIDER SCOOTER, LY-EW4022Cleared 510(K)
- K013763WU'S 4-WHEELED NEO SCOOTER, WT-L42Cleared 510(K)
- K014119WU'S 3-WHEELED NEO SCOOTER, WT-M32Cleared 510(K)
- K021371SUNSPEX TECHNOLOGIES MODEL SE 022Cleared 510(K)
- K020002MODEL P-33, BATTERY OPERATED, THREE WHEEL, POWER SCOOTER , MODEL P-332Cleared 510(K)
- K020001PF-3, BATTERY OPERATED, FOUR WHEEL, POWER SCOOTER, MODEL PF-32Cleared 510(K)
- K013927MINI SHOPPER2Cleared 510(K)
- K013788TRAVEL EASE ELECTRIC SCOOTER, MODEL PIONEER 52Cleared 510(K)
- K012258COMPANION MODEL 221, 321, 4212Cleared 510(K)
- K011473SNAZZY22Cleared 510(K)
- K011476SOVEREIGN2Cleared 510(K)
- K012791C.T.M. MOBILITY SCOOTER MODEL # HS-3202Cleared 510(K)
- K012792C.T.M. MOBITIY SCOOTER MODEL #HS-3602Cleared 510(K)
- K012592EASYTRAVEL2Cleared 510(K)
- K011751TRAVEL EASE ELECTRIC SCOOTER, MODEL PIONEER 32Cleared 510(K)
- K011753TRAVEL EASE ELECTRIC SCOOTER, MODEL PIONEER 42Cleared 510(K)
- K011707TRAVEL EASE ELECTRIC SCOOTER MODEL # PIONEER 22Cleared 510(K)
- K011401RAMBLER2Cleared 510(K)
- K010503AMIGO WHEELCHAIR2Cleared 510(K)
- K011107MODIFICATION TO SOLO2Cleared 510(K)
- K010606SAFARI2Cleared 510(K)
- K003058LASER 3 SPSC3002Cleared 510(K)
- K003059LASER 4SPSC3402Cleared 510(K)
- K010135MODELS LYNX AND PANTHER MOTORIZED SCOOTERS, MODELS LYNX SX-3, LYNX SX-3P, LYNX LX-3, LYNX LX-3, PANTHER LX-42Cleared 510(K)
- K003815TRAVEL EASE ELECTRIC SCOOTER, MODEL PIONEER2Cleared 510(K)
- K002616ELECTRIC MOBILITY RASCAL AND CHAUFFER SCOOTERS2Cleared 510(K)
- K001835IRV2000 INDIVIDUAL RECREATIONAL VEHICLE2Cleared 510(K)
- K000356C.T.M. MOBILITY SCOOTER, MODEL H2-686, HS-740, HS-5802Cleared 510(K)
- K000354C.T.M. MOBILITY SCOOTERS HS-666, HS-730, HS-5702Cleared 510(K)
- K000869LA PERSONAL SCOOTER2Cleared 510(K)
- K984565TMC-EASY-3022Cleared 510(K)
- K994127GLORY2Cleared 510(K)
- K991281ELECTRIC MOBILITY CAVALIER SCOOTERS2Cleared 510(K)
- K991132ACTIVA2Cleared 510(K)
- K992052MODELS LYNX AND PANTHER MOTORIZED SCOOTERS2Cleared 510(K)
- K983987AMIGO MODEL 5900002Cleared 510(K)
- K982145MEGA 32Cleared 510(K)
- K982144MEGA 42Cleared 510(K)
- K983663C.T.M. MOBILITY SCOOTER, MODEL # HS-6662Cleared 510(K)
- K983662C.T.M. MOBILITY SCOOTER, MODEL # HS-6862Cleared 510(K)
- K981885SUNRISE SCOOTER SERIES, MODEL UNASSIGNED, 3 WHEEL STANDARD MODEL, 3 WHEEL MID RANGE MODEL, 3 WHEEL HIGH END MODEL, 4 WHE2Cleared 510(K)
- K983405ACEME JUPITER SCOOTER, 3-WHEELED, MODEL JUPITER 502Cleared 510(K)
- K983407ACEME JUPITER SCOOTER, 4-WHEELED,MODEL JUPITER 50F2Cleared 510(K)
- K981121AMIGO RT2Cleared 510(K)
- K970646SAFARI2Cleared 510(K)
- K971050GOLDEN HAWK2Cleared 510(K)
- K971043GOLDEN EAGLE2Cleared 510(K)
- K971387FREERIDER, MODEL FR510-F2Cleared 510(K)
- K971388FREERIDER, MODEL FR168-42Cleared 510(K)
- K965123PACE SAVER, LITTLE JUNIOR (MODIFICATION)(MOTORIZED THREE-WHEELED VEHICLE)2Cleared 510(K)
- K972037PROWLER2Cleared 510(K)
- K972038INTRUDER2Cleared 510(K)
- K972036STEALTH2Cleared 510(K)
- K970523SOLO2Cleared 510(K)
- K964954SUPERLIGHT2Cleared 510(K)
- K962583CAT SCOOTER WITH DS60 VONYTOLLRT2Cleared 510(K)
- K955274BOOSTER LITE 3 MOTORIZED SCOOTER2Cleared 510(K)
- K955275BOOSTER TROPHY 5 MOTORIZED SCOOTER2Cleared 510(K)
- K955276BOOSTER LITE 4 MOTORIZED SCOOTER2Cleared 510(K)
- K961888PILLAR 4-WHEEL SCOOTER2Cleared 510(K)
- K954378FORMULA IV ELECTRIC MOBILITY VEHICLE2Cleared 510(K)
- K954974PACE SAVER LITTLE JUNIOR (MODIFICATION)2Cleared 510(K)
- K952042TRAVEL EASE ELECTRIC SCOOTER, MODEL: PIONEER2Cleared 510(K)
- K944940EURO SC5002Cleared 510(K)
- K952112AMIGO GRAND TOUR2Cleared 510(K)
- K944277DYNAMO2Cleared 510(K)
- K944939CELEBRITY XL SC4452Cleared 510(K)
- K942508ROBO2Cleared 510(K)
- K940334AMIGO J-92Cleared 510(K)
- K941966CAT SCOOTER2Cleared 510(K)
- K931231SIDEKICK II2Cleared 510(K)
- K925122PACE SAVER LITTLE JR2Cleared 510(K)
- K930953CELEBRITY SC4402Cleared 510(K)
- K930952PRIDE LEGEND SC-3402Cleared 510(K)
- K926499SHUTTLE SC-1402Cleared 510(K)
- K926296CELEBRITY SC4002Cleared 510(K)
- K926295LEGEND SC 3002Cleared 510(K)
- K924515ELECTRIC MOBILITY RASCAL2Cleared 510(K)
- K923796BOBCAT2Cleared 510(K)
- K922967FORTRESS 1700FS REAR WHEEL DRIVE SCOOTER2Cleared 510(K)
- K922966FORTRESS 1704FS FOUR WHEEL SCOOTER2Cleared 510(K)
- K915416FYMCO FLYER2Cleared 510(K)
- K923193SUNRUNNER TE-7772Cleared 510(K)
- K922304ROADRUNNER ELECTRIC SCOOTER-3 WHEELED2Cleared 510(K)
- K922305COYOTE ELECTRIC SCOOTER-3WHEELED2Cleared 510(K)
- K922338X-330/SPIRIT MOTORIZED THREE-WHEELED SCOOTER2Cleared 510(K)
- K921647REGAL MOTORIZIED 3 WHEELED VEHICLE2Cleared 510(K)
- K921467DRAKE & DRAKE/200 DL2Cleared 510(K)
- K921069FORTRESS 1800FS REAR WHEEL DRIVE SCOOTER2Cleared 510(K)
- K920654SHOPRIDER - TE8892Cleared 510(K)
- K915659THREE WHEEL SCOOTER2Cleared 510(K)
- K913989510 DL POWERED WHEELCHAIRS2Cleared 510(K)
- K910751FORTRESS 1600ACV REAR WHEEL DRIVE SCOOTER2Cleared 510(K)
- K910265TRAVELER, MOTORIZED THREE-WHEELED VEHICLE2Cleared 510(K)
- K905271PRIDE SPIRIT2Cleared 510(K)
- K905245SPORTS RIDER AND SHOP RIDER2Cleared 510(K)
- K904522VARIOUS MODELS OF WHEELCHAIRS2Cleared 510(K)
- K901586TRI-ROLLS REAR WHEEL DRIVE POWERED SCOOTER2Cleared 510(K)
- K900738BOOSTER MOTORIZED THREE WHEELED VEHICLE2Cleared 510(K)
- K900600TRI-SCOOT FRONT WHEEL DRIVE POWERED SCOOTER2Cleared 510(K)
- K900042FORTRESS BUDDY FRONT WHEEL DRIVE SCOOTER2Cleared 510(K)
- K900041FORTRESS LIBERATOR RWD SCOOTER2Cleared 510(K)
- K896025THE SHUTTLE (TM) THREE WHEEL SCOOTER2Cleared 510(K)
- K895692FORTRESS MODEL 2001LX ELECTRIC 3-WHEELER2Cleared 510(K)
- K895693FORTRESS 2000FS 3-WHEEL SCOOTER2Cleared 510(K)
- K895694FORTRESS MODEL 2200FS FRONT WHEEL DRIVE SCOOTER2Cleared 510(K)
- K894112RAOMER2Cleared 510(K)
- K893429ALPHA CONDOR2Cleared 510(K)
- K893248ALPHA MALLARD2Cleared 510(K)
- K891609CARRETTE 3 WHEELED MOTORIZED CART2Cleared 510(K)
- K881766REM 250 THREE WHEELED ELECTRIC CART2Cleared 510(K)
- K880425STERLING (MOTORIZED VEHICLE)2Cleared 510(K)
- K880424SCOOTA BUG (MOTORIZED VEHICLE)2Cleared 510(K)
- K873500MINI CROSSER BATTERY POWERED WHEELCHAIR2Cleared 510(K)
- K873609VEHICLE, MOTORIZED (3-WHEELED ELECTRIC CART)2Cleared 510(K)
- K872518REM500 THREE WHEELED ELEC. CART.2Cleared 510(K)
- K864686SCOOTA MOTORIZED VEHICLE2Cleared 510(K)
- K853918THE SPORTSTER (ELECTRIFIED WHEELCHAIR)2Cleared 510(K)
- K853766ALPHA SUPER KART2Cleared 510(K)
- K852557ALL TERRAIN AMIGO2Cleared 510(K)
- K852380SPARROW MOTORIZED SCOOTER2Cleared 510(K)
- K851256MOBIE SCOOTER2Cleared 510(K)
- K841919ALPHA TRI-KART2Cleared 510(K)
- K840866PORTASCOOT POWER SEAT2Cleared 510(K)
- K840196MINI-BEEP2Cleared 510(K)
- K834506PACESAVER & SCOUT2Cleared 510(K)
- K832727MOBIE2Cleared 510(K)
- K830345SCOOTER, VEHICLE MOTORIZED2Cleared 510(K)
- K822696MASTER I2Cleared 510(K)
- 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
- 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
PACE SAVER, LITTLE JUNIOR (MODIFICATION)(MOTORIZED THREE-WHEELED VEHICLE)
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K965123
- 510(k) Type
- Traditional
- Applicant
- BURKE, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 7/17/1997
- Days to Decision
- 244 days
- Submission Type
- Statement