Product Code: INI FDA class 2 21 CFR 890.3800

Vehicle, Motorized 3-Wheeled

Physical Medicine

A Motorized 3-Wheeled Vehicle is a powered mobility device designed for individuals with impaired mobility who require a compact, maneuverable alternative to a powered wheelchair, providing independent transportation for persons with lower limb disabilities or reduced walking capacity. It is classified as FDA Class 2, representing moderate risk, meaning it requires a 510(k) premarket notification demonstrating substantial equivalence to a predicate device before marketing. The product code is INI, regulated under 21 CFR 890.3800, within the Physical Medicine medical specialty. This device is eligible for third party review, meaning the 510(k) submission may be reviewed by an FDA-accredited third party organization.

510(k)s
347
FEI Numbers
71
Registration Numbers
71
Unique Applicants
131
Years Active
44

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Basic Information

Product Code
INI
Device Class
FDA class 2
Regulation Number
890.3800
Medical Specialty
Physical Medicine
Review Panel
PM
Submission Type
1

Device Characteristics

GMP Exempt
Implant
Life Sustain/Support
Third Party
Summary Malfunction Reporting

510(k) Clearance History

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Related 510(k) Clearances

This FDA classification is associated with 347 510(k) clearances via K numbers.

K Number Device Name
K253257 Virgo Mobility Scooter (Virgo-D,Virgo-F)
K253600 Scooter (YD-03)
K260717 Mobility Scooter (Air Carbon)
K260237 Mobility Scooter (X-12, X-14, X-17)
K252813 Electrical Scooter (SM4226)
K253936 Power Mobility Scooter (MJMA01, MJMA02)
K253631 Mobility Scooter (CL-Q3, CL-Q4)
K253643 Mobility Scooter (S3)
K252349 Electric Scooter (Mojo-T330)
K252347 Electric Scooter (Mojo-T580)
K252275 Electric Scooter (DDF100)
K253075 Mobility scooter (Air Classic); Mobility scooter (Air Traveller); Mobility scooter (Air Traveller2.0)
K252817 Mobility Scooter (BC-MS310)
K252835 Electric Scooter (S202572J, S2060, M2089, S2050)
K252588 Mobility Scooter (T5)
K252590 Powered Mobility Scooter (PMS105, GUT177, GCAT047)
K252502 Folding Mobility Scooter (KD101)
K251799 Mobility Scooter (BBR-Q40-01); Mobility Scooter (BBR-Q40-02); Mobility Scooter (BBR-Q40-03); Mobility Scooter (BBR-Q40-04); Mobility Scooter (BBR-Q40-05); Mobility Scooter (BBR-Q40-06)
K251638 Mobility Scooter (MS160C)
K243102 Mobility Scooter (JT10)
K250533 Magnesium alloy scooter (RS100)
K242975 Mobility Scooter (Model X-01, X-02)
K250027 Powered Mobility Scooter
K242982 Mobility Scooter (MS160A)
K242714 Mobility Scooter (S-01); Mobility Scooter (S-02)
K240590 Electrical Scooter, WT-T4SU
K242760 WHILL Model R
K242139 Mobility Scooter (YL-09B, YL-07)
K242628 Scooter (PS30)
K242387 Mobility Scooter (N3473)
K240990 Mobility Scooter
K232692 Powered Mobility Scooter (Models: PMS101, GUT112, PMS103, GUT140)
K240272 Electric Scooter (M2085, S2091)
K240008 Mobility Scooter (W3331)
K240012 Mobility Scooter (W3431)
K234098 Mobility Scooter (C4+)
K231472 Mobility Scooter (S1 SPORT, S1 PLUS, MAX SPORT)
K231428 Mobility Scooter (Models: W3431D)
K230001 Electric Scooter (Model: M2020)
K222703 ATTO Mobility Scooter (ATTO);ATTO Mobility Scooter (ATTO SPORT);ATTO Mobility Scooter (ATTO SPORT MAX)
K230615 Electric Scooter (Model: S3312)
K222729 Electrical Scooter, WT-T4QP2
K222507 Mobility Scooter (Models: W3431Q, W3431R)
K223492 eFOLDi Scooter, Lite
K222711 HS186B Scooter
K222495 Mobility Scooter, Model: W3331F
K220227 Auto Folding Scooter, S21F
K212090 Electric Scooter
K220207 Mobility Scooter, Model W3468
K220206 Mobility Scooter
K191356 i3 Foldable Mobility Scooter
K201196 Scooter (Model: FDB01)
K190737 Solax Electric Scooter (Models: S204311M, S204161, S204143)
K192190 Solax Electric Scooter
K202549 Solax Electric Scooter (Model: S202261B)
K191897 Solax Electric Scooter (Models: S3023, S3024, S3025, S3026)
K192308 Wu's Electrical Scooter
K192885 C.T.M. Mobility Scooter HS-268
K182631 SupaScoota Motorized vehicle - Spartan (Sumo)/ Spartan SP (Sumo SP)
K182471 Scooter
K182411 Scooter, Model: R-100
K181344 C.T.M Mobility Scooter
K172440 Solax Electric Scooter, Models: S302121, S302131, S302141, S302151
K172409 Lite
K170634 Quingo Classic Power Scooter S1301, Quingo Flyte Power Scooter S551, Quingo Toura Power Scooter 5350
K171256 Quingo Flyte Mobility Scooter
K162952 C.T.M. Mobility Scooter
K163201 KYMCO EQ10D Scooter
K160835 Titan 3W
K160909 ATTO Mobility Scooter
K151656 HEARTWAY Power Mobility Scooter
K150998 HEARTWAY Power Mobility Scooter
K150987 HEARTWAY Power Mobility Scooter, BRIO S19
K143557 SupaScoota Motorized vehicle
K151944 Luggie Super
K150086 Titan
K142912 Merits Yoga Power Scooter, S542
K142162 MERITS TRANSFORMER POWER SCOOTER, S941
K133187 FREERIDER FR1, models FR1-13, FR1-15, FR1-17
K132855 HEARTWAY POWER MOBILITY SCOOTER
K131302 SOLAX
K130940 KYMCO EQ20C SCOOTER
K122749 PRESTIGE-MOBIE
K110165 FREERIDER MODEL LUGGIE MODEL 168-4IT
K103771 LOTUS BLAKE ESTEEM SCOOTER
K110567 C.T.M. MOBILITY SCOOTER HS515(3W)
K110395 C.T.M. MOBILITY SCOOTER - MODEL HS 118
K102304 BREEZE C MODEL C (3W), BREEZE C (4W)
K102361 ZIP'R4/ ZIP'R4 XTRA SCOOTER
K102358 ZIP'R3/ ZIP'R3 XTRA SCOOTER
K101507 AMIGO CLASSIC FD
K101143 HEARTWAY POWER MOBILITY SCOOTER, S11
K101142 HEARTWAY LIGHTWEIGHT POWER MOBILITY SCOOTER, S34
K092650 HEARTWAY POWER MOBILITY SCOOTER, S12
K092155 HEARTWAY POWER MOBILITY SCOOTER, S8
K092154 HEARTWAY POWER MOBILITY SCOOTER, S9
K092088 VICTORY XL 130 FOUR WHEEL SCOOTER, MODEL SC713
K091418 C.T.M. MOBILITY SCOOTER, MODEL HS-628, INVACARE ORION
K090735 C.T.M. MOBILITY SCOOTER, HS-528
K091212 WU'S 3 WHEELED ELECTRICAL SCOOTER, WT-T3H
K090966 AMIGO CATEGORY III FULL-SIZED REGULAR DUTY 3 WHEEL (310000) AND AMIGO CATEGORY V HEAVY DUTY 3 WHEEL (650000)
K091113 MAXIMA V, THREE WHEEL SCOOTER, MODEL SC900V MAXIMA V, FOUR WHEEL SCOOTER, MODEL SC940V
K090805 V10, THREE WHEEL SCOOTER, MODEL SC610V, V10, THREE WHEEL SCOOTER, MODEL SC610VPS, V10, FOUR WHEEL SCOOTER, MODEL SC710
K090524 GO GO ELITE TRAVELER V THREE WHEEL SCOOTER, MODEL SC40EV
K083303 LANDLEX, MODEL: 402X
K082963 WU'S 4-WHEELED NEO SCOOTER, WT-M3A
K082901 KYMCO FORU, MODEL EQ20
K082900 KYMCO FORU, MODEL EQ10
K081980 KYMCO FORU, MODEL EQ35
K081133 KYMCO FORU, MODEL EQ40
K080242 HEARTWAY POWER MOBILITY SCOOTER, PF7
K080288 TRAVEL PAL FOUR WHEEL SCOOTER, MODEL MM114
K073044 HEARTWAY POWER MOBILITY SCOOTER, MODEL PT7
K072712 COMFORT ELECTRIC SCOOTER, LY-EW408
K072630 FORU, MODEL EQ30
K072337 WU'S 4-WHEELED NEO SCOOTER, MODEL WT-M4A
K072165 VICTORY THREE WHEEL SCOOTER, MODEL: SC610
K072104 HEARTWAY POWER MOBILITY SCOOTER, PF6
K071949 VICTORY, 4 WHEEL SCOOTER / MODEL, # SC1740
K071282 MODEL SEGAEGO 4D SCOOTER
K071284 MODEL SEGAEGO 3D SCOOTER
K071007 HEARTWAY LIGHTWEIGHT POWER MOBILITY SCOOTER, S33
K070817 LERADOTECH SCOOTER, MODEL SB
K070802 LERADOTECH, MODEL SC
K070602 C.T.M. MOBILITY SCOOTER# HS-265
K070493 HEARTWAY POWER TILT SEATING SYSTEM POWER CHAIR, P17RT
K070603 C.T.M. MOBILITTY SCOOTER # HS-295
K062646 RUIKE, MODEL 3411
K070025 C.T.M. MOBILITY SCOOTER, MODEL HS-310
K063196 LANDLEX, MODEL S403X
K062645 RUIKE, MODEL 3431
K062676 RUIKE, MODEL 3331
K063030 COMFORT SCOOTER MODEL LY-EW406
K063389 GO GO ELITE TRAVELLER PLUS 4 WHEEL SCOOTER, MODEL SC54
K063162 GOLDEN LITEWAY
K063032 COMFORT SCOOTER, MODEL LY-EW415
K062790 WU'S 3-WHEELED NEO SCOOTER, MODEL WT-T3E
K062160 GO GO MINI, MODEL SC30
K061912 FUSION
K060697 TRAVEL PAL (MM-111B) /MEGA MOTION
K060068 AVANTICARE, MODEL SA4021
K052204 THE ELITE - ULTRA-LIGHT, COMPACT PORTABLE SCOOTER
K060042 LANDLEX, MODEL P100X
K051028 BREEZE
K052558 VCS, MODEL S4T
K052673 KING I POWERED SCOOTER, MODEL CTL-11
K052486 PROASIA, MODEL L4501
K052378 PROASIA, MODEL L3402
K051130 VCS S3Y
K051473 LEARDO, AVANTICARE ELECTRICAL SCOOTERSM3021
K051131 VCS S3T
K051538 AVANTICARE, MODEL SA4022
K050793 LANDLEX MODEL S400X
K050507 SMARTECH, MODEL HOLI I
K051118 MODEL TL-360 POWER SCOOTER
K051116 MODEL TL-560 POWER SCOOTER
K050792 LANDLEX, MODEL S300X
K050042 WU'S 4-WHEELED NEO SCOOTER, WT-XL4
K043326 BEWELL, MODEL SC 20
K042104 AMERICAN BANTEX, MODEL MS 3
K042764 MEDLINE STRIDER MIDI 4
K042763 MODIFICATION TO MEDLINE STRIDER MIDI 3
K042012 TEH LIN POWER SCOOTER, MODEL TL-822
K042011 POWER SCOOTER, MODEL TL0821
K042010 POWER SCOOTER, MODEL TL-688
K041677 KARMA SCOOTER, MODEL KS-747.2
K040754 AMERICAN BANTEX MS 4 MINI SCOOTER
K041193 A&I SCOOTER, SC-402
K041187 A&I SCOOTER, SC-301
K041055 MEDLINE STRIDER MAXI 4
K041054 MEDLINE STRIDER MAXI 3
K041053 MEDLINE STRIDER MICRO 3
K040838 MEDLINE STRIDER MINI 4
K040818 MEDLINE STRIDER MINI 3
K041025 BUZZAROUND, VEHICLE, MOTORIZED 3-WHEELED
K040968 WU'S 4-WHEELED NEO SCOOTER, MODEL WT-T4D
K033116 OPTI-RIDER DELUXE
K040097 MEDLINE STRIDER MIDI 3
K032446 MEDLINE STRIDER, MODELS MIDI 3 AND MIDI 4
K033019 SUNPEX TECHNOLOGIES MODEL SE03
K033240 BE-MOBILE 3-WHEELED ELECTRIC SCOOTER, MODEL DK S200
K033220 BE-MOBILE 4-WHEELED ELECTRIC SCOOTER, MODEL DK S280
K032645 JUSTWIN SCOOTER, JS-3014
K032643 JUSTWIN SCOOTER, JS-3013
K032488 WU'S 3-WHEELED NEO SCOOTER, WT-T3D
K032879 NAVIGATOR I
K033239 BE-MOBILE 4-WHEELED ELECTRIC SCOOTER, MODEL DK S500
K033219 BE-MOBILE 4-WHEELED ELECTRIC SCOOTER, MODEL DK S600
K033204 ESG 4-WHEEL SCOOTER, ESG-03
K032617 WU'S 4-WHEELED SCOOTER, WT-L4JR
K033241 BE-MOBILE 3-WHEELED ELECTRIC SCOOTER, MODEL DK S320
K033032 WU'S 3-WHEELED NEO SCOOTER, MODEL WT-M3JR
K032919 C.T.M. MOBILITY SCOOTER, MODEL HS-250
K032918 C.T.M. MOBILITY SCOOTER, MODEL HS-235
K030757 COACH 777-4
K030756 COACH 777-3
K032489 WU'S 4-WHEELED NEO SCOOTER, WT-M4JR
K032277 JUSTWIN SCOOTER, MODEL JS-401
K031897 PF-2 BATTERY OPERATED ELECTRIC FOUR WHEEL POWER SCOOTER
K031315 TMC ELECTRICAL SCOOTER, EASY 321
K031314 TMC ELECTRICAL SCOOTER, EASY 411
K031313 TMC ELECTRICAL SCOOTER, EASY 405
K031309 KUANN DAH, COOL TANK MOTORIZED SCOOTER, KS4L320
K030758 COACH 888
K031272 C.T.M. MOBILITY SCOOTER, MODEL HS-120
K030759 LITTLE COACH
K024325 JI-EE ELECTRIC SCOOTER, ESTHETE ES 1
K024329 JI-EE ELECTRIC SCOOTER, ELEGANCE ES 3
K030814 INVACARE ADVENTURE SERIES SCOOTERS, MODELS ADVENTURE SX-3 & LX-3
K030387 C.T.M. MOBILITY SCOOTER, MODEL HS-890
K023168 WU'S 3-WHEELED NEO SCOOTER, WT-T3B
K023166 WU'S 3-WHEELED NEO SCOOTER, WT-M4
K023040 WU'S 3-WHEELED NEO SCOOTER, WT-L3
K023581 COMFORT AGILE SCOOTER, LY-EW303
K022698 SCOOTER MARS SERIES, MODEL TL-588
K022518 J.P. 3-WHEELED SCOOTER, ES-350 CITYBUG II/ RABBIT
K021925 SUNPEX TECHNOLOGIES MODEL SE 01
K022369 COMFORT WINDJOY SCOOTER, MODEL LY-EW302
K021910 COMFORT DREAMRIDER SCOOTER, LY-EW402
K013763 WU'S 4-WHEELED NEO SCOOTER, WT-L4
K014119 WU'S 3-WHEELED NEO SCOOTER, WT-M3
K021371 SUNSPEX TECHNOLOGIES MODEL SE 02
K020002 MODEL P-33, BATTERY OPERATED, THREE WHEEL, POWER SCOOTER , MODEL P-33
K020001 PF-3, BATTERY OPERATED, FOUR WHEEL, POWER SCOOTER, MODEL PF-3
K013927 MINI SHOPPER
K013788 TRAVEL EASE ELECTRIC SCOOTER, MODEL PIONEER 5
K012258 COMPANION MODEL 221, 321, 421
K011473 SNAZZY2
K011476 SOVEREIGN
K012792 C.T.M. MOBITIY SCOOTER MODEL #HS-360
K012791 C.T.M. MOBILITY SCOOTER MODEL # HS-320
K012592 EASYTRAVEL
K011751 TRAVEL EASE ELECTRIC SCOOTER, MODEL PIONEER 3
K011753 TRAVEL EASE ELECTRIC SCOOTER, MODEL PIONEER 4
K011707 TRAVEL EASE ELECTRIC SCOOTER MODEL # PIONEER 2
K011401 RAMBLER
K010503 AMIGO WHEELCHAIR
K011107 MODIFICATION TO SOLO
K010606 SAFARI
K003058 LASER 3 SPSC300
K003059 LASER 4SPSC340
K010135 MODELS LYNX AND PANTHER MOTORIZED SCOOTERS, MODELS LYNX SX-3, LYNX SX-3P, LYNX LX-3, LYNX LX-3, PANTHER LX-4
K003815 TRAVEL EASE ELECTRIC SCOOTER, MODEL PIONEER
K002616 ELECTRIC MOBILITY RASCAL AND CHAUFFER SCOOTERS
K001835 IRV2000 INDIVIDUAL RECREATIONAL VEHICLE
K000356 C.T.M. MOBILITY SCOOTER, MODEL H2-686, HS-740, HS-580
K000354 C.T.M. MOBILITY SCOOTERS HS-666, HS-730, HS-570
K000869 LA PERSONAL SCOOTER
K984565 TMC-EASY-302
K994127 GLORY
K991281 ELECTRIC MOBILITY CAVALIER SCOOTERS
K991132 ACTIVA
K992052 MODELS LYNX AND PANTHER MOTORIZED SCOOTERS
K983987 AMIGO MODEL 590000
K982145 MEGA 3
K982144 MEGA 4
K983663 C.T.M. MOBILITY SCOOTER, MODEL # HS-666
K983662 C.T.M. MOBILITY SCOOTER, MODEL # HS-686
K981885 SUNRISE SCOOTER SERIES, MODEL UNASSIGNED, 3 WHEEL STANDARD MODEL, 3 WHEEL MID RANGE MODEL, 3 WHEEL HIGH END MODEL, 4 WHE
K983407 ACEME JUPITER SCOOTER, 4-WHEELED,MODEL JUPITER 50F
K983405 ACEME JUPITER SCOOTER, 3-WHEELED, MODEL JUPITER 50
K981121 AMIGO RT
K970646 SAFARI
K971050 GOLDEN HAWK
K971043 GOLDEN EAGLE
K971388 FREERIDER, MODEL FR168-4
K971387 FREERIDER, MODEL FR510-F
K965123 PACE SAVER, LITTLE JUNIOR (MODIFICATION)(MOTORIZED THREE-WHEELED VEHICLE)
K972038 INTRUDER
K972037 PROWLER
K972036 STEALTH
K970523 SOLO
K964954 SUPERLIGHT
K962583 CAT SCOOTER WITH DS60 VONYTOLLRT
K955276 BOOSTER LITE 4 MOTORIZED SCOOTER
K955275 BOOSTER TROPHY 5 MOTORIZED SCOOTER
K955274 BOOSTER LITE 3 MOTORIZED SCOOTER
K961888 PILLAR 4-WHEEL SCOOTER
K954378 FORMULA IV ELECTRIC MOBILITY VEHICLE
K954974 PACE SAVER LITTLE JUNIOR (MODIFICATION)
K952042 TRAVEL EASE ELECTRIC SCOOTER, MODEL: PIONEER
K944940 EURO SC500
K952112 AMIGO GRAND TOUR
K944277 DYNAMO
K944939 CELEBRITY XL SC445
K942508 ROBO
K940334 AMIGO J-9
K941966 CAT SCOOTER
K931231 SIDEKICK II
K925122 PACE SAVER LITTLE JR
K930953 CELEBRITY SC440
K930952 PRIDE LEGEND SC-340
K926499 SHUTTLE SC-140
K926296 CELEBRITY SC400
K926295 LEGEND SC 300
K924515 ELECTRIC MOBILITY RASCAL
K923796 BOBCAT
K922967 FORTRESS 1700FS REAR WHEEL DRIVE SCOOTER
K922966 FORTRESS 1704FS FOUR WHEEL SCOOTER
K915416 FYMCO FLYER
K923193 SUNRUNNER TE-777
K922305 COYOTE ELECTRIC SCOOTER-3WHEELED
K922304 ROADRUNNER ELECTRIC SCOOTER-3 WHEELED
K922338 X-330/SPIRIT MOTORIZED THREE-WHEELED SCOOTER
K921647 REGAL MOTORIZIED 3 WHEELED VEHICLE
K921467 DRAKE & DRAKE/200 DL
K921069 FORTRESS 1800FS REAR WHEEL DRIVE SCOOTER
K920654 SHOPRIDER - TE889
K915659 THREE WHEEL SCOOTER
K913989 510 DL POWERED WHEELCHAIRS
K910751 FORTRESS 1600ACV REAR WHEEL DRIVE SCOOTER
K910265 TRAVELER, MOTORIZED THREE-WHEELED VEHICLE
K905271 PRIDE SPIRIT
K905245 SPORTS RIDER AND SHOP RIDER
K904522 VARIOUS MODELS OF WHEELCHAIRS
K901586 TRI-ROLLS REAR WHEEL DRIVE POWERED SCOOTER
K900738 BOOSTER MOTORIZED THREE WHEELED VEHICLE
K900600 TRI-SCOOT FRONT WHEEL DRIVE POWERED SCOOTER
K900042 FORTRESS BUDDY FRONT WHEEL DRIVE SCOOTER
K900041 FORTRESS LIBERATOR RWD SCOOTER
K896025 THE SHUTTLE (TM) THREE WHEEL SCOOTER
K895692 FORTRESS MODEL 2001LX ELECTRIC 3-WHEELER
K895693 FORTRESS 2000FS 3-WHEEL SCOOTER
K895694 FORTRESS MODEL 2200FS FRONT WHEEL DRIVE SCOOTER
K894112 RAOMER
K893429 ALPHA CONDOR
K893248 ALPHA MALLARD
K891609 CARRETTE 3 WHEELED MOTORIZED CART
K881766 REM 250 THREE WHEELED ELECTRIC CART
K880425 STERLING (MOTORIZED VEHICLE)
K880424 SCOOTA BUG (MOTORIZED VEHICLE)
K873500 MINI CROSSER BATTERY POWERED WHEELCHAIR
K873609 VEHICLE, MOTORIZED (3-WHEELED ELECTRIC CART)
K872518 REM500 THREE WHEELED ELEC. CART.
K864686 SCOOTA MOTORIZED VEHICLE
K853918 THE SPORTSTER (ELECTRIFIED WHEELCHAIR)
K853766 ALPHA SUPER KART
K852557 ALL TERRAIN AMIGO
K852380 SPARROW MOTORIZED SCOOTER
K851256 MOBIE SCOOTER
K841919 ALPHA TRI-KART
K840866 PORTASCOOT POWER SEAT
K840196 MINI-BEEP
K834506 PACESAVER & SCOUT
K832727 MOBIE
K830345 SCOOTER, VEHICLE MOTORIZED
K822696 MASTER I

FEI Numbers

This FDA classification entry is associated with 71 FEI numbers. Click on an entry to view related FDA registrations.

Registration Numbers

This FDA classification entry is associated with 71 registration numbers. Click on an entry to view related FDA registrations.