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Miscellaneous
Miscellaneous
Subpart B—Physical Medicine Diagnostic Devices
CFR Sub-Part
Subpart D—Physical Medicine Prosthetic Devices
CFR Sub-Part
IMK
Wheelchair, Stair Climbing
2
Product Code
IML
Armrest, Wheelchair
1
Product Code
IMM
Footrest, Wheelchair
1
Product Code
IMN
Climber, Curb, Wheelchair
1
Product Code
IMO
Handrim, Wheelchair
1
Product Code
IMP
Cushion, Wheelchair
1
Product Code
IMQ
Attachment, Narrowing, Wheelchair
1
Product Code
IMR
Device, Anti-Tip, Wheelchair
1
Product Code
QNX
External Compression Device For Internal Jugular Vein Compression
2
Product Code
ILE
Sling, Arm, Overhead Supported
1
Product Code
ILG
Stocking, Elastic
1
Product Code
ILH
Splint, Hand, And Components
1
Product Code
ILI
Sling, Arm
1
Product Code
ILP
System, Communication, Non-Powered
1
Product Code
ILQ
System, Communication, Powered
2
Product Code
IMS
Support, Head And Trunk, Wheelchair
1
Product Code
IMW
Brake, Extension, Wheelchair
1
Product Code
IMX
Board, Lap, Wheelchair
1
Product Code
IMY
Armboard, Wheelchair
1
Product Code
IMZ
Holder, Crutch And Cane, Wheelchair
1
Product Code
INA
Hill Holder, Wheelchair
1
Product Code
INB
Attachment, Commode, Wheelchair
1
Product Code
INC
Cuff, Pusher, Wheelchair
1
Product Code
INE
Sling, Overhead Suspension, Wheelchair
1
Product Code
INF
Scale, Platform, Wheelchair
1
Product Code
ING
Elevator, Wheelchair, Portable
2
Product Code
INI
Vehicle, Motorized 3-Wheeled
2
Product Code
K
25
0027
Powered Mobility Scooter
2
Cleared 510(K)
K
24
2982
Mobility Scooter (MS160A)
2
Cleared 510(K)
K
24
2714
Mobility Scooter (S-01); Mobility Scooter (S-02)
2
Cleared 510(K)
K
24
0590
Electrical Scooter, WT-T4SU
2
Cleared 510(K)
K
24
2760
WHILL Model R
2
Cleared 510(K)
K
24
2139
Mobility Scooter (YL-09B, YL-07)
2
Cleared 510(K)
K
24
2628
Scooter (PS30)
2
Cleared 510(K)
K
24
2387
Mobility Scooter (N3473)
2
Cleared 510(K)
K
24
0990
Mobility Scooter
2
Cleared 510(K)
K
23
2692
Powered Mobility Scooter (Models: PMS101, GUT112, PMS103, GUT140)
2
Cleared 510(K)
K
24
0272
Electric Scooter (M2085, S2091)
2
Cleared 510(K)
K
24
0008
Mobility Scooter (W3331)
2
Cleared 510(K)
K
24
0012
Mobility Scooter (W3431)
2
Cleared 510(K)
K
23
4098
Mobility Scooter (C4+)
2
Cleared 510(K)
K
23
1472
Mobility Scooter (S1 SPORT, S1 PLUS, MAX SPORT)
2
Cleared 510(K)
K
23
1428
Mobility Scooter (Models: W3431D)
2
Cleared 510(K)
K
23
0001
Electric Scooter (Model: M2020)
2
Cleared 510(K)
K
22
2703
ATTO Mobility Scooter (ATTO);ATTO Mobility Scooter (ATTO SPORT);ATTO Mobility Scooter (ATTO SPORT MAX)
2
Cleared 510(K)
K
23
0615
Electric Scooter (Model: S3312)
2
Cleared 510(K)
K
22
2729
Electrical Scooter, WT-T4QP2
2
Cleared 510(K)
K
22
2507
Mobility Scooter (Models: W3431Q, W3431R)
2
Cleared 510(K)
K
22
3492
eFOLDi Scooter, Lite
2
Cleared 510(K)
K
22
2711
HS186B Scooter
2
Cleared 510(K)
K
22
2495
Mobility Scooter, Model: W3331F
2
Cleared 510(K)
K
22
0227
Auto Folding Scooter, S21F
2
Cleared 510(K)
K
21
2090
Electric Scooter
2
Cleared 510(K)
K
22
0206
Mobility Scooter
2
Cleared 510(K)
K
22
0207
Mobility Scooter, Model W3468
2
Cleared 510(K)
K
19
1356
i3 Foldable Mobility Scooter
2
Cleared 510(K)
K
20
1196
Scooter (Model: FDB01)
2
Cleared 510(K)
K
19
0737
Solax Electric Scooter (Models: S204311M, S204161, S204143)
2
Cleared 510(K)
K
19
2190
Solax Electric Scooter
2
Cleared 510(K)
K
20
2549
Solax Electric Scooter (Model: S202261B)
2
Cleared 510(K)
K
19
1897
Solax Electric Scooter (Models: S3023, S3024, S3025, S3026)
2
Cleared 510(K)
K
19
2308
Wu's Electrical Scooter
2
Cleared 510(K)
K
19
2885
C.T.M. Mobility Scooter HS-268
2
Cleared 510(K)
K
18
2631
SupaScoota Motorized vehicle - Spartan (Sumo)/ Spartan SP (Sumo SP)
2
Cleared 510(K)
K
18
2471
Scooter
2
Cleared 510(K)
K
18
2411
Scooter, Model: R-100
2
Cleared 510(K)
K
18
1344
C.T.M Mobility Scooter
2
Cleared 510(K)
K
17
2440
Solax Electric Scooter, Models: S302121, S302131, S302141, S302151
2
Cleared 510(K)
K
17
2409
Lite
2
Cleared 510(K)
K
17
0634
Quingo Classic Power Scooter S1301, Quingo Flyte Power Scooter S551, Quingo Toura Power Scooter 5350
2
Cleared 510(K)
K
17
1256
Quingo Flyte Mobility Scooter
2
Cleared 510(K)
K
16
2952
C.T.M. Mobility Scooter
2
Cleared 510(K)
K
16
3201
KYMCO EQ10D Scooter
2
Cleared 510(K)
K
16
0835
Titan 3W
2
Cleared 510(K)
K
16
0909
ATTO Mobility Scooter
2
Cleared 510(K)
K
15
1656
HEARTWAY Power Mobility Scooter
2
Cleared 510(K)
K
15
0998
HEARTWAY Power Mobility Scooter
2
Cleared 510(K)
K
15
0987
HEARTWAY Power Mobility Scooter, BRIO S19
2
Cleared 510(K)
K
14
3557
SupaScoota Motorized vehicle
2
Cleared 510(K)
K
15
1944
Luggie Super
2
Cleared 510(K)
K
15
0086
Titan
2
Cleared 510(K)
K
14
2912
Merits Yoga Power Scooter, S542
2
Cleared 510(K)
K
14
2162
MERITS TRANSFORMER POWER SCOOTER, S941
2
Cleared 510(K)
K
13
3187
FREERIDER FR1, models FR1-13, FR1-15, FR1-17
2
Cleared 510(K)
K
13
2855
HEARTWAY POWER MOBILITY SCOOTER
2
Cleared 510(K)
K
13
1302
SOLAX
2
Cleared 510(K)
K
13
0940
KYMCO EQ20C SCOOTER
2
Cleared 510(K)
K
12
2749
PRESTIGE-MOBIE
2
Cleared 510(K)
K
11
0165
FREERIDER MODEL LUGGIE MODEL 168-4IT
2
Cleared 510(K)
K
10
3771
LOTUS BLAKE ESTEEM SCOOTER
2
Cleared 510(K)
K
11
0567
C.T.M. MOBILITY SCOOTER HS515(3W)
2
Cleared 510(K)
K
11
0395
C.T.M. MOBILITY SCOOTER - MODEL HS 118
2
Cleared 510(K)
K
10
2304
BREEZE C MODEL C (3W), BREEZE C (4W)
2
Cleared 510(K)
K
10
2361
ZIP'R4/ ZIP'R4 XTRA SCOOTER
2
Cleared 510(K)
K
10
2358
ZIP'R3/ ZIP'R3 XTRA SCOOTER
2
Cleared 510(K)
K
10
1507
AMIGO CLASSIC FD
2
Cleared 510(K)
K
10
1142
HEARTWAY LIGHTWEIGHT POWER MOBILITY SCOOTER, S34
2
Cleared 510(K)
K
10
1143
HEARTWAY POWER MOBILITY SCOOTER, S11
2
Cleared 510(K)
K
09
2650
HEARTWAY POWER MOBILITY SCOOTER, S12
2
Cleared 510(K)
K
09
2155
HEARTWAY POWER MOBILITY SCOOTER, S8
2
Cleared 510(K)
K
09
2154
HEARTWAY POWER MOBILITY SCOOTER, S9
2
Cleared 510(K)
K
09
2088
VICTORY XL 130 FOUR WHEEL SCOOTER, MODEL SC713
2
Cleared 510(K)
K
09
1418
C.T.M. MOBILITY SCOOTER, MODEL HS-628, INVACARE ORION
2
Cleared 510(K)
K
09
0735
C.T.M. MOBILITY SCOOTER, HS-528
2
Cleared 510(K)
K
09
1212
WU'S 3 WHEELED ELECTRICAL SCOOTER, WT-T3H
2
Cleared 510(K)
K
09
0966
AMIGO CATEGORY III FULL-SIZED REGULAR DUTY 3 WHEEL (310000) AND AMIGO CATEGORY V HEAVY DUTY 3 WHEEL (650000)
2
Cleared 510(K)
K
09
1113
MAXIMA V, THREE WHEEL SCOOTER, MODEL SC900V MAXIMA V, FOUR WHEEL SCOOTER, MODEL SC940V
2
Cleared 510(K)
K
09
0805
V10, THREE WHEEL SCOOTER, MODEL SC610V, V10, THREE WHEEL SCOOTER, MODEL SC610VPS, V10, FOUR WHEEL SCOOTER, MODEL SC710
2
Cleared 510(K)
K
09
0524
GO GO ELITE TRAVELER V THREE WHEEL SCOOTER, MODEL SC40EV
2
Cleared 510(K)
K
08
3303
LANDLEX, MODEL: 402X
2
Cleared 510(K)
K
08
2963
WU'S 4-WHEELED NEO SCOOTER, WT-M3A
2
Cleared 510(K)
K
08
2900
KYMCO FORU, MODEL EQ10
2
Cleared 510(K)
K
08
2901
KYMCO FORU, MODEL EQ20
2
Cleared 510(K)
K
08
1980
KYMCO FORU, MODEL EQ35
2
Cleared 510(K)
K
08
1133
KYMCO FORU, MODEL EQ40
2
Cleared 510(K)
K
08
0242
HEARTWAY POWER MOBILITY SCOOTER, PF7
2
Cleared 510(K)
K
08
0288
TRAVEL PAL FOUR WHEEL SCOOTER, MODEL MM114
2
Cleared 510(K)
K
07
3044
HEARTWAY POWER MOBILITY SCOOTER, MODEL PT7
2
Cleared 510(K)
K
07
2712
COMFORT ELECTRIC SCOOTER, LY-EW408
2
Cleared 510(K)
K
07
2630
FORU, MODEL EQ30
2
Cleared 510(K)
K
07
2337
WU'S 4-WHEELED NEO SCOOTER, MODEL WT-M4A
2
Cleared 510(K)
K
07
2165
VICTORY THREE WHEEL SCOOTER, MODEL: SC610
2
Cleared 510(K)
K
07
2104
HEARTWAY POWER MOBILITY SCOOTER, PF6
2
Cleared 510(K)
K
07
1949
VICTORY, 4 WHEEL SCOOTER / MODEL, # SC1740
2
Cleared 510(K)
K
07
1282
MODEL SEGAEGO 4D SCOOTER
2
Cleared 510(K)
K
07
1284
MODEL SEGAEGO 3D SCOOTER
2
Cleared 510(K)
K
07
1007
HEARTWAY LIGHTWEIGHT POWER MOBILITY SCOOTER, S33
2
Cleared 510(K)
K
07
0817
LERADOTECH SCOOTER, MODEL SB
2
Cleared 510(K)
K
07
0802
LERADOTECH, MODEL SC
2
Cleared 510(K)
K
07
0602
C.T.M. MOBILITY SCOOTER# HS-265
2
Cleared 510(K)
K
07
0493
HEARTWAY POWER TILT SEATING SYSTEM POWER CHAIR, P17RT
2
Cleared 510(K)
K
07
0603
C.T.M. MOBILITTY SCOOTER # HS-295
2
Cleared 510(K)
K
06
2646
RUIKE, MODEL 3411
2
Cleared 510(K)
K
07
0025
C.T.M. MOBILITY SCOOTER, MODEL HS-310
2
Cleared 510(K)
K
06
3196
LANDLEX, MODEL S403X
2
Cleared 510(K)
K
06
2645
RUIKE, MODEL 3431
2
Cleared 510(K)
K
06
2676
RUIKE, MODEL 3331
2
Cleared 510(K)
K
06
3030
COMFORT SCOOTER MODEL LY-EW406
2
Cleared 510(K)
K
06
3389
GO GO ELITE TRAVELLER PLUS 4 WHEEL SCOOTER, MODEL SC54
2
Cleared 510(K)
K
06
3162
GOLDEN LITEWAY
2
Cleared 510(K)
K
06
3032
COMFORT SCOOTER, MODEL LY-EW415
2
Cleared 510(K)
K
06
2790
WU'S 3-WHEELED NEO SCOOTER, MODEL WT-T3E
2
Cleared 510(K)
K
06
2160
GO GO MINI, MODEL SC30
2
Cleared 510(K)
K
06
1912
FUSION
2
Cleared 510(K)
K
06
0697
TRAVEL PAL (MM-111B) /MEGA MOTION
2
Cleared 510(K)
K
06
0068
AVANTICARE, MODEL SA4021
2
Cleared 510(K)
K
05
2204
THE ELITE - ULTRA-LIGHT, COMPACT PORTABLE SCOOTER
2
Cleared 510(K)
K
06
0042
LANDLEX, MODEL P100X
2
Cleared 510(K)
K
05
1028
BREEZE
2
Cleared 510(K)
K
05
2558
VCS, MODEL S4T
2
Cleared 510(K)
K
05
2673
KING I POWERED SCOOTER, MODEL CTL-11
2
Cleared 510(K)
K
05
2486
PROASIA, MODEL L4501
2
Cleared 510(K)
K
05
2378
PROASIA, MODEL L3402
2
Cleared 510(K)
K
05
1130
VCS S3Y
2
Cleared 510(K)
K
05
1473
LEARDO, AVANTICARE ELECTRICAL SCOOTERSM3021
2
Cleared 510(K)
K
05
1131
VCS S3T
2
Cleared 510(K)
K
05
1538
AVANTICARE, MODEL SA4022
2
Cleared 510(K)
K
05
0793
LANDLEX MODEL S400X
2
Cleared 510(K)
K
05
0507
SMARTECH, MODEL HOLI I
2
Cleared 510(K)
K
05
1116
MODEL TL-560 POWER SCOOTER
2
Cleared 510(K)
K
05
1118
MODEL TL-360 POWER SCOOTER
2
Cleared 510(K)
K
05
0792
LANDLEX, MODEL S300X
2
Cleared 510(K)
K
05
0042
WU'S 4-WHEELED NEO SCOOTER, WT-XL4
2
Cleared 510(K)
K
04
3326
BEWELL, MODEL SC 20
2
Cleared 510(K)
K
04
2104
AMERICAN BANTEX, MODEL MS 3
2
Cleared 510(K)
K
04
2764
MEDLINE STRIDER MIDI 4
2
Cleared 510(K)
K
04
2763
MODIFICATION TO MEDLINE STRIDER MIDI 3
2
Cleared 510(K)
K
04
2012
TEH LIN POWER SCOOTER, MODEL TL-822
2
Cleared 510(K)
K
04
2011
POWER SCOOTER, MODEL TL0821
2
Cleared 510(K)
K
04
2010
POWER SCOOTER, MODEL TL-688
2
Cleared 510(K)
K
04
1677
KARMA SCOOTER, MODEL KS-747.2
2
Cleared 510(K)
K
04
0754
AMERICAN BANTEX MS 4 MINI SCOOTER
2
Cleared 510(K)
K
04
1193
A&I SCOOTER, SC-402
2
Cleared 510(K)
K
04
1187
A&I SCOOTER, SC-301
2
Cleared 510(K)
K
04
1055
MEDLINE STRIDER MAXI 4
2
Cleared 510(K)
K
04
1054
MEDLINE STRIDER MAXI 3
2
Cleared 510(K)
K
04
1053
MEDLINE STRIDER MICRO 3
2
Cleared 510(K)
K
04
0838
MEDLINE STRIDER MINI 4
2
Cleared 510(K)
K
04
0818
MEDLINE STRIDER MINI 3
2
Cleared 510(K)
K
04
1025
BUZZAROUND, VEHICLE, MOTORIZED 3-WHEELED
2
Cleared 510(K)
K
04
0968
WU'S 4-WHEELED NEO SCOOTER, MODEL WT-T4D
2
Cleared 510(K)
K
03
3116
OPTI-RIDER DELUXE
2
Cleared 510(K)
K
04
0097
MEDLINE STRIDER MIDI 3
2
Cleared 510(K)
K
03
2446
MEDLINE STRIDER, MODELS MIDI 3 AND MIDI 4
2
Cleared 510(K)
K
03
3019
SUNPEX TECHNOLOGIES MODEL SE03
2
Cleared 510(K)
K
03
3240
BE-MOBILE 3-WHEELED ELECTRIC SCOOTER, MODEL DK S200
2
Cleared 510(K)
K
03
3220
BE-MOBILE 4-WHEELED ELECTRIC SCOOTER, MODEL DK S280
2
Cleared 510(K)
K
03
2645
JUSTWIN SCOOTER, JS-3014
2
Cleared 510(K)
K
03
2643
JUSTWIN SCOOTER, JS-3013
2
Cleared 510(K)
K
03
2488
WU'S 3-WHEELED NEO SCOOTER, WT-T3D
2
Cleared 510(K)
K
03
2879
NAVIGATOR I
2
Cleared 510(K)
K
03
3239
BE-MOBILE 4-WHEELED ELECTRIC SCOOTER, MODEL DK S500
2
Cleared 510(K)
K
03
3219
BE-MOBILE 4-WHEELED ELECTRIC SCOOTER, MODEL DK S600
2
Cleared 510(K)
K
03
3204
ESG 4-WHEEL SCOOTER, ESG-03
2
Cleared 510(K)
K
03
2617
WU'S 4-WHEELED SCOOTER, WT-L4JR
2
Cleared 510(K)
K
03
3241
BE-MOBILE 3-WHEELED ELECTRIC SCOOTER, MODEL DK S320
2
Cleared 510(K)
K
03
3032
WU'S 3-WHEELED NEO SCOOTER, MODEL WT-M3JR
2
Cleared 510(K)
K
03
2919
C.T.M. MOBILITY SCOOTER, MODEL HS-250
2
Cleared 510(K)
K
03
2918
C.T.M. MOBILITY SCOOTER, MODEL HS-235
2
Cleared 510(K)
K
03
0756
COACH 777-3
2
Cleared 510(K)
K
03
0757
COACH 777-4
2
Cleared 510(K)
K
03
2489
WU'S 4-WHEELED NEO SCOOTER, WT-M4JR
2
Cleared 510(K)
K
03
2277
JUSTWIN SCOOTER, MODEL JS-401
2
Cleared 510(K)
K
03
1897
PF-2 BATTERY OPERATED ELECTRIC FOUR WHEEL POWER SCOOTER
2
Cleared 510(K)
K
03
1315
TMC ELECTRICAL SCOOTER, EASY 321
2
Cleared 510(K)
K
03
1314
TMC ELECTRICAL SCOOTER, EASY 411
2
Cleared 510(K)
K
03
1313
TMC ELECTRICAL SCOOTER, EASY 405
2
Cleared 510(K)
K
03
1309
KUANN DAH, COOL TANK MOTORIZED SCOOTER, KS4L320
2
Cleared 510(K)
K
03
0758
COACH 888
2
Cleared 510(K)
K
03
1272
C.T.M. MOBILITY SCOOTER, MODEL HS-120
2
Cleared 510(K)
K
03
0759
LITTLE COACH
2
Cleared 510(K)
K
02
4325
JI-EE ELECTRIC SCOOTER, ESTHETE ES 1
2
Cleared 510(K)
K
02
4329
JI-EE ELECTRIC SCOOTER, ELEGANCE ES 3
2
Cleared 510(K)
K
03
0814
INVACARE ADVENTURE SERIES SCOOTERS, MODELS ADVENTURE SX-3 & LX-3
2
Cleared 510(K)
K
03
0387
C.T.M. MOBILITY SCOOTER, MODEL HS-890
2
Cleared 510(K)
K
02
3166
WU'S 3-WHEELED NEO SCOOTER, WT-M4
2
Cleared 510(K)
K
02
3168
WU'S 3-WHEELED NEO SCOOTER, WT-T3B
2
Cleared 510(K)
K
02
3040
WU'S 3-WHEELED NEO SCOOTER, WT-L3
2
Cleared 510(K)
K
02
3581
COMFORT AGILE SCOOTER, LY-EW303
2
Cleared 510(K)
K
02
2698
SCOOTER MARS SERIES, MODEL TL-588
2
Cleared 510(K)
K
02
2518
J.P. 3-WHEELED SCOOTER, ES-350 CITYBUG II/ RABBIT
2
Cleared 510(K)
K
02
1925
SUNPEX TECHNOLOGIES MODEL SE 01
2
Cleared 510(K)
K
02
2369
COMFORT WINDJOY SCOOTER, MODEL LY-EW302
2
Cleared 510(K)
K
02
1910
COMFORT DREAMRIDER SCOOTER, LY-EW402
2
Cleared 510(K)
K
01
3763
WU'S 4-WHEELED NEO SCOOTER, WT-L4
2
Cleared 510(K)
K
01
4119
WU'S 3-WHEELED NEO SCOOTER, WT-M3
2
Cleared 510(K)
K
02
1371
SUNSPEX TECHNOLOGIES MODEL SE 02
2
Cleared 510(K)
K
02
0002
MODEL P-33, BATTERY OPERATED, THREE WHEEL, POWER SCOOTER , MODEL P-33
2
Cleared 510(K)
K
02
0001
PF-3, BATTERY OPERATED, FOUR WHEEL, POWER SCOOTER, MODEL PF-3
2
Cleared 510(K)
K
01
3927
MINI SHOPPER
2
Cleared 510(K)
K
01
3788
TRAVEL EASE ELECTRIC SCOOTER, MODEL PIONEER 5
2
Cleared 510(K)
K
01
2258
COMPANION MODEL 221, 321, 421
2
Cleared 510(K)
K
01
1473
SNAZZY2
2
Cleared 510(K)
K
01
1476
SOVEREIGN
2
Cleared 510(K)
K
01
2792
C.T.M. MOBITIY SCOOTER MODEL #HS-360
2
Cleared 510(K)
K
01
2791
C.T.M. MOBILITY SCOOTER MODEL # HS-320
2
Cleared 510(K)
K
01
2592
EASYTRAVEL
2
Cleared 510(K)
K
01
1751
TRAVEL EASE ELECTRIC SCOOTER, MODEL PIONEER 3
2
Cleared 510(K)
K
01
1753
TRAVEL EASE ELECTRIC SCOOTER, MODEL PIONEER 4
2
Cleared 510(K)
K
01
1707
TRAVEL EASE ELECTRIC SCOOTER MODEL # PIONEER 2
2
Cleared 510(K)
K
01
1401
RAMBLER
2
Cleared 510(K)
K
01
0503
AMIGO WHEELCHAIR
2
Cleared 510(K)
K
01
1107
MODIFICATION TO SOLO
2
Cleared 510(K)
K
01
0606
SAFARI
2
Cleared 510(K)
K
00
3058
LASER 3 SPSC300
2
Cleared 510(K)
K
00
3059
LASER 4SPSC340
2
Cleared 510(K)
K
01
0135
MODELS LYNX AND PANTHER MOTORIZED SCOOTERS, MODELS LYNX SX-3, LYNX SX-3P, LYNX LX-3, LYNX LX-3, PANTHER LX-4
2
Cleared 510(K)
K
00
3815
TRAVEL EASE ELECTRIC SCOOTER, MODEL PIONEER
2
Cleared 510(K)
K
00
2616
ELECTRIC MOBILITY RASCAL AND CHAUFFER SCOOTERS
2
Cleared 510(K)
K
00
1835
IRV2000 INDIVIDUAL RECREATIONAL VEHICLE
2
Cleared 510(K)
K
00
0356
C.T.M. MOBILITY SCOOTER, MODEL H2-686, HS-740, HS-580
2
Cleared 510(K)
K
00
0354
C.T.M. MOBILITY SCOOTERS HS-666, HS-730, HS-570
2
Cleared 510(K)
K
00
0869
LA PERSONAL SCOOTER
2
Cleared 510(K)
K
98
4565
TMC-EASY-302
2
Cleared 510(K)
K
99
4127
GLORY
2
Cleared 510(K)
K
99
1281
ELECTRIC MOBILITY CAVALIER SCOOTERS
2
Cleared 510(K)
K
99
1132
ACTIVA
2
Cleared 510(K)
K
99
2052
MODELS LYNX AND PANTHER MOTORIZED SCOOTERS
2
Cleared 510(K)
K
98
3987
AMIGO MODEL 590000
2
Cleared 510(K)
K
98
2145
MEGA 3
2
Cleared 510(K)
K
98
2144
MEGA 4
2
Cleared 510(K)
K
98
3663
C.T.M. MOBILITY SCOOTER, MODEL # HS-666
2
Cleared 510(K)
K
98
3662
C.T.M. MOBILITY SCOOTER, MODEL # HS-686
2
Cleared 510(K)
K
98
1885
SUNRISE SCOOTER SERIES, MODEL UNASSIGNED, 3 WHEEL STANDARD MODEL, 3 WHEEL MID RANGE MODEL, 3 WHEEL HIGH END MODEL, 4 WHE
2
Cleared 510(K)
K
98
3405
ACEME JUPITER SCOOTER, 3-WHEELED, MODEL JUPITER 50
2
Cleared 510(K)
K
98
3407
ACEME JUPITER SCOOTER, 4-WHEELED,MODEL JUPITER 50F
2
Cleared 510(K)
K
98
1121
AMIGO RT
2
Cleared 510(K)
K
97
0646
SAFARI
2
Cleared 510(K)
K
97
1043
GOLDEN EAGLE
2
Cleared 510(K)
K
97
1050
GOLDEN HAWK
2
Cleared 510(K)
K
97
1388
FREERIDER, MODEL FR168-4
2
Cleared 510(K)
K
97
1387
FREERIDER, MODEL FR510-F
2
Cleared 510(K)
K
96
5123
PACE SAVER, LITTLE JUNIOR (MODIFICATION)(MOTORIZED THREE-WHEELED VEHICLE)
2
Cleared 510(K)
K
97
2036
STEALTH
2
Cleared 510(K)
K
97
2038
INTRUDER
2
Cleared 510(K)
K
97
2037
PROWLER
2
Cleared 510(K)
K
97
0523
SOLO
2
Cleared 510(K)
K
96
4954
SUPERLIGHT
2
Cleared 510(K)
K
96
2583
CAT SCOOTER WITH DS60 VONYTOLLRT
2
Cleared 510(K)
K
95
5274
BOOSTER LITE 3 MOTORIZED SCOOTER
2
Cleared 510(K)
K
95
5275
BOOSTER TROPHY 5 MOTORIZED SCOOTER
2
Cleared 510(K)
K
95
5276
BOOSTER LITE 4 MOTORIZED SCOOTER
2
Cleared 510(K)
K
96
1888
PILLAR 4-WHEEL SCOOTER
2
Cleared 510(K)
K
95
4378
FORMULA IV ELECTRIC MOBILITY VEHICLE
2
Cleared 510(K)
K
95
4974
PACE SAVER LITTLE JUNIOR (MODIFICATION)
2
Cleared 510(K)
K
95
2042
TRAVEL EASE ELECTRIC SCOOTER, MODEL: PIONEER
2
Cleared 510(K)
K
94
4940
EURO SC500
2
Cleared 510(K)
K
95
2112
AMIGO GRAND TOUR
2
Cleared 510(K)
K
94
4277
DYNAMO
2
Cleared 510(K)
K
94
4939
CELEBRITY XL SC445
2
Cleared 510(K)
K
94
2508
ROBO
2
Cleared 510(K)
K
94
0334
AMIGO J-9
2
Cleared 510(K)
K
94
1966
CAT SCOOTER
2
Cleared 510(K)
K
93
1231
SIDEKICK II
2
Cleared 510(K)
K
92
5122
PACE SAVER LITTLE JR
2
Cleared 510(K)
K
93
0952
PRIDE LEGEND SC-340
2
Cleared 510(K)
K
93
0953
CELEBRITY SC440
2
Cleared 510(K)
K
92
6499
SHUTTLE SC-140
2
Cleared 510(K)
K
92
6296
CELEBRITY SC400
2
Cleared 510(K)
K
92
6295
LEGEND SC 300
2
Cleared 510(K)
K
92
4515
ELECTRIC MOBILITY RASCAL
2
Cleared 510(K)
K
92
3796
BOBCAT
2
Cleared 510(K)
K
92
2967
FORTRESS 1700FS REAR WHEEL DRIVE SCOOTER
2
Cleared 510(K)
K
92
2966
FORTRESS 1704FS FOUR WHEEL SCOOTER
2
Cleared 510(K)
K
91
5416
FYMCO FLYER
2
Cleared 510(K)
K
92
3193
SUNRUNNER TE-777
2
Cleared 510(K)
K
92
2305
COYOTE ELECTRIC SCOOTER-3WHEELED
2
Cleared 510(K)
K
92
2304
ROADRUNNER ELECTRIC SCOOTER-3 WHEELED
2
Cleared 510(K)
K
92
2338
X-330/SPIRIT MOTORIZED THREE-WHEELED SCOOTER
2
Cleared 510(K)
K
92
1647
REGAL MOTORIZIED 3 WHEELED VEHICLE
2
Cleared 510(K)
K
92
1467
DRAKE & DRAKE/200 DL
2
Cleared 510(K)
K
92
1069
FORTRESS 1800FS REAR WHEEL DRIVE SCOOTER
2
Cleared 510(K)
K
92
0654
SHOPRIDER - TE889
2
Cleared 510(K)
K
91
5659
THREE WHEEL SCOOTER
2
Cleared 510(K)
K
91
3989
510 DL POWERED WHEELCHAIRS
2
Cleared 510(K)
K
91
0751
FORTRESS 1600ACV REAR WHEEL DRIVE SCOOTER
2
Cleared 510(K)
K
91
0265
TRAVELER, MOTORIZED THREE-WHEELED VEHICLE
2
Cleared 510(K)
K
90
5271
PRIDE SPIRIT
2
Cleared 510(K)
K
90
5245
SPORTS RIDER AND SHOP RIDER
2
Cleared 510(K)
K
90
4522
VARIOUS MODELS OF WHEELCHAIRS
2
Cleared 510(K)
K
90
1586
TRI-ROLLS REAR WHEEL DRIVE POWERED SCOOTER
2
Cleared 510(K)
K
90
0738
BOOSTER MOTORIZED THREE WHEELED VEHICLE
2
Cleared 510(K)
K
90
0600
TRI-SCOOT FRONT WHEEL DRIVE POWERED SCOOTER
2
Cleared 510(K)
K
90
0042
FORTRESS BUDDY FRONT WHEEL DRIVE SCOOTER
2
Cleared 510(K)
K
90
0041
FORTRESS LIBERATOR RWD SCOOTER
2
Cleared 510(K)
K
89
6025
THE SHUTTLE (TM) THREE WHEEL SCOOTER
2
Cleared 510(K)
K
89
5692
FORTRESS MODEL 2001LX ELECTRIC 3-WHEELER
2
Cleared 510(K)
K
89
5693
FORTRESS 2000FS 3-WHEEL SCOOTER
2
Cleared 510(K)
K
89
5694
FORTRESS MODEL 2200FS FRONT WHEEL DRIVE SCOOTER
2
Cleared 510(K)
K
89
4112
RAOMER
2
Cleared 510(K)
K
89
3429
ALPHA CONDOR
2
Cleared 510(K)
K
89
3248
ALPHA MALLARD
2
Cleared 510(K)
K
89
1609
CARRETTE 3 WHEELED MOTORIZED CART
2
Cleared 510(K)
K
88
1766
REM 250 THREE WHEELED ELECTRIC CART
2
Cleared 510(K)
K
88
0425
STERLING (MOTORIZED VEHICLE)
2
Cleared 510(K)
K
88
0424
SCOOTA BUG (MOTORIZED VEHICLE)
2
Cleared 510(K)
K
87
3500
MINI CROSSER BATTERY POWERED WHEELCHAIR
2
Cleared 510(K)
K
87
3609
VEHICLE, MOTORIZED (3-WHEELED ELECTRIC CART)
2
Cleared 510(K)
K
87
2518
REM500 THREE WHEELED ELEC. CART.
2
Cleared 510(K)
K
86
4686
SCOOTA MOTORIZED VEHICLE
2
Cleared 510(K)
K
85
3918
THE SPORTSTER (ELECTRIFIED WHEELCHAIR)
2
Cleared 510(K)
K
85
3766
ALPHA SUPER KART
2
Cleared 510(K)
K
85
2557
ALL TERRAIN AMIGO
2
Cleared 510(K)
K
85
2380
SPARROW MOTORIZED SCOOTER
2
Cleared 510(K)
K
85
1256
MOBIE SCOOTER
2
Cleared 510(K)
K
84
1919
ALPHA TRI-KART
2
Cleared 510(K)
K
84
0866
PORTASCOOT POWER SEAT
2
Cleared 510(K)
K
84
0196
MINI-BEEP
2
Cleared 510(K)
K
83
4506
PACESAVER & SCOUT
2
Cleared 510(K)
K
83
2727
MOBIE
2
Cleared 510(K)
K
83
0345
SCOOTER, VEHICLE MOTORIZED
2
Cleared 510(K)
K
82
2696
MASTER I
2
Cleared 510(K)
INK
Stretcher, Wheeled, Powered
2
Product Code
INM
Chair, With Casters
1
Product Code
INN
Chair, Adjustable, Mechanical
1
Product Code
INO
Chair, Positioning, Electric
2
Product Code
INP
Tips And Pads, Cane, Crutch And Walker
1
Product Code
INQ
Table, Powered
1
Product Code
INT
Plinth
1
Product Code
INW
Table, Mechanical
1
Product Code
IOR
Wheelchair, Mechanical
1
Product Code
IOY
Support, Arm
1
Product Code
IOZ
Splint, Abduction, Congenital Hip Dislocation
1
Product Code
IPG
Shoe, Cast
1
Product Code
IPL
Wheelchair, Standup
2
Product Code
IPM
Cover, Limb
1
Product Code
IPO
Orthosis, Pneumatic Structure, Rigid
3
Product Code
IPR
Crutch
1
Product Code
IPS
Cane
1
Product Code
IPT
Orthosis, Thoracic
1
Product Code
IPW
Orthosis, Sacroiliac, Soft
1
Product Code
IPX
Orthosis, Rib Fracture, Soft
1
Product Code
IPY
Orthosis, Lumbo-Sacral
1
Product Code
IQA
System, Environmental Control, Powered
2
Product Code
IQB
Belt, Wheelchair
1
Product Code
IQC
Wheelchair, Special Grade
2
Product Code
IQE
Orthosis, Lumbar
1
Product Code
IQF
Orthosis, Cervical-Thoracic, Rigid
1
Product Code
IQI
Orthosis, Limb Brace
1
Product Code
IQJ
Splint, Clavicle
1
Product Code
IQK
Orthosis, Cervical
1
Product Code
IQM
Splint, Temporary Training
1
Product Code
IQO
Device, Prosthesis Alignment
1
Product Code
IQP
Rotator, Transverse
1
Product Code
IQQ
Joint, Shoulder, External Limb Component
1
Product Code
IQW
Hook, External Limb Component, Powered
1
Product Code
IQX
Hook, External Limb Component, Mechanical
1
Product Code
IQZ
Hand, External Limb Component, Powered
1
Product Code
IRA
Hand, External Limb Component, Mechanical
1
Product Code
IRD
Joint, Elbow, External Limb Component, Mechanical
1
Product Code
IRE
Joint, Elbow, External Limb Component, Powered
1
Product Code
ISH
Component, External, Limb, Ankle/Foot
1
Product Code
ISL
Joint, Hip, External Limb Component
1
Product Code
ISM
Pylon, Post Surgical
1
Product Code
ISN
Cable
1
Product Code
ISP
Valve, Prosthesis
1
Product Code
ISR
Band Or Belt, Pelvic Support
1
Product Code
ISS
Prosthesis, Thigh Socket, External Component
1
Product Code
ISW
Assembly, Knee/Shank/Ankle/Foot, External
2
Product Code
ISY
Joint, Knee, External Limb Component
1
Product Code
ISZ
Unit, Wrist, External Limb Component, Mechanical
1
Product Code
ITC
Stirrup, External Brace Component
1
Product Code
ITG
Bandage, Cast
1
Product Code
ITI
Wheelchair, Powered
2
Product Code
ITJ
Walker, Mechanical
1
Product Code
ITM
Cage, Knee
1
Product Code
ITN
Splint, Denis Brown
1
Product Code
ITO
Twister, Brace Setting
1
Product Code
ITQ
Joint, Knee, External Brace
1
Product Code
ITS
Joint, Hip, External Brace
1
Product Code
ITW
Joint, Ankle, External Brace
1
Product Code
KFT
Assembly, Shoulder/Elbow/Forearm/Wrist/Hand, Mechanical
1
Product Code
KFW
Assembly, Shoulder/Elbow/Forearm/Wrist/Hand, Powered
1
Product Code
KFX
Assembly, Thigh/Knee/Shank/Ankle/Foot, External
2
Product Code
KGH
Unit, Wrist, External Limb Component, Powered
1
Product Code
KHY
Cane, Safety Walk
1
Product Code
KIC
Cushion, Flotation
1
Product Code
KID
Restraint, Wheelchair, Non-Protective
1
Product Code
KNN
Components, Wheelchair
1
Product Code
KNO
Accessories, Wheelchair
1
Product Code
KNP
Orthosis, Corrective Shoe
1
Product Code
KTD
Orthosis, Abdominal
1
Product Code
LBE
Stroller, Adaptive
1
Product Code
LFF
Unit, Activation, Breath Control
1
Product Code
MNE
Orthosis, Moldable, Supportive, Skin Protective
1
Product Code
MRI
Orthosis, Truncal/Orthosis, Limb
1
Product Code
NDA
Helmet, Cranial, For Protective Use
1
Product Code
NHF
Monitor, Orthotic/Prosthetic
1
Product Code
NJB
Orthosis, Truncal, For Dysmenorrhea
1
Product Code
NXE
Walker, Mechanical, Poly Vinyl Chloride (Pvc)
1
Product Code
OHI
Orthosis, Foot Drop
1
Product Code
PAE
Upper Extremity Prosthesis With Multiple Simultaneous Degrees Of Freedom And Controlled Via Cutaneous Electromyography
2
Product Code
PCE
Permanently Mounted Wheelchair Platform Lift
2
Product Code
PMV
Orthosis, Limb, For Back Pain
1
Product Code
QDT
Shoe With Adjustable Sole Units
1
Product Code
Subpart E—Surgical Devices
CFR Sub-Part
Subpart F—Neurological Therapeutic Devices
CFR Sub-Part
Subpart F—Physical Medicine Therapeutic Devices
CFR Sub-Part
Radiology
Review Panel
General and Plastic Surgery
Review Panel
Toxicology
Review Panel
Medical Genetics
Review Panel
Unknown
Review Panel
Last synced on 18 April 2025 at 11:05 pm
PM
/
subpart-d—physical-medicine-prosthetic-devices
/
INI
/
K024329
View Source
JI-EE ELECTRIC SCOOTER, ELEGANCE ES 3
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K024329
510(k) Type
Traditional
Applicant
JI-EE INDUSTRY CO., LTD.
Country
Taiwan
FDA Decision
Substantially Equivalent
Decision Date
3/21/2003
Days to Decision
85 days
Submission Type
Statement
FDA Browser
by
Innolitics
Anesthesiology
Cardiovascular
Chemistry
Dental
Ear, Nose, Throat
Gastroenterology and Urology
General Hospital
Hematology
Immunology
Microbiology
Neurology
Obstetrical and Gynecological
Ophthalmic
Orthopedic
Pathology
Physical Medicine
Miscellaneous
Subpart B—Physical Medicine Diagnostic Devices
Subpart D—Physical Medicine Prosthetic Devices
IMK
Wheelchair, Stair Climbing
IML
Armrest, Wheelchair
IMM
Footrest, Wheelchair
IMN
Climber, Curb, Wheelchair
IMO
Handrim, Wheelchair
IMP
Cushion, Wheelchair
IMQ
Attachment, Narrowing, Wheelchair
IMR
Device, Anti-Tip, Wheelchair
QNX
External Compression Device For Internal Jugular Vein Compression
ILE
Sling, Arm, Overhead Supported
ILG
Stocking, Elastic
ILH
Splint, Hand, And Components
ILI
Sling, Arm
ILP
System, Communication, Non-Powered
ILQ
System, Communication, Powered
IMS
Support, Head And Trunk, Wheelchair
IMW
Brake, Extension, Wheelchair
IMX
Board, Lap, Wheelchair
IMY
Armboard, Wheelchair
IMZ
Holder, Crutch And Cane, Wheelchair
INA
Hill Holder, Wheelchair
INB
Attachment, Commode, Wheelchair
INC
Cuff, Pusher, Wheelchair
INE
Sling, Overhead Suspension, Wheelchair
INF
Scale, Platform, Wheelchair
ING
Elevator, Wheelchair, Portable
INI
Vehicle, Motorized 3-Wheeled
K
25
0027
Powered Mobility Scooter
K
24
2982
Mobility Scooter (MS160A)
K
24
2714
Mobility Scooter (S-01); Mobility Scooter (S-02)
K
24
0590
Electrical Scooter, WT-T4SU
K
24
2760
WHILL Model R
K
24
2139
Mobility Scooter (YL-09B, YL-07)
K
24
2628
Scooter (PS30)
K
24
2387
Mobility Scooter (N3473)
K
24
0990
Mobility Scooter
K
23
2692
Powered Mobility Scooter (Models: PMS101, GUT112, PMS103, GUT140)
K
24
0272
Electric Scooter (M2085, S2091)
K
24
0008
Mobility Scooter (W3331)
K
24
0012
Mobility Scooter (W3431)
K
23
4098
Mobility Scooter (C4+)
K
23
1472
Mobility Scooter (S1 SPORT, S1 PLUS, MAX SPORT)
K
23
1428
Mobility Scooter (Models: W3431D)
K
23
0001
Electric Scooter (Model: M2020)
K
22
2703
ATTO Mobility Scooter (ATTO);ATTO Mobility Scooter (ATTO SPORT);ATTO Mobility Scooter (ATTO SPORT MAX)
K
23
0615
Electric Scooter (Model: S3312)
K
22
2729
Electrical Scooter, WT-T4QP2
K
22
2507
Mobility Scooter (Models: W3431Q, W3431R)
K
22
3492
eFOLDi Scooter, Lite
K
22
2711
HS186B Scooter
K
22
2495
Mobility Scooter, Model: W3331F
K
22
0227
Auto Folding Scooter, S21F
K
21
2090
Electric Scooter
K
22
0206
Mobility Scooter
K
22
0207
Mobility Scooter, Model W3468
K
19
1356
i3 Foldable Mobility Scooter
K
20
1196
Scooter (Model: FDB01)
K
19
0737
Solax Electric Scooter (Models: S204311M, S204161, S204143)
K
19
2190
Solax Electric Scooter
K
20
2549
Solax Electric Scooter (Model: S202261B)
K
19
1897
Solax Electric Scooter (Models: S3023, S3024, S3025, S3026)
K
19
2308
Wu's Electrical Scooter
K
19
2885
C.T.M. Mobility Scooter HS-268
K
18
2631
SupaScoota Motorized vehicle - Spartan (Sumo)/ Spartan SP (Sumo SP)
K
18
2471
Scooter
K
18
2411
Scooter, Model: R-100
K
18
1344
C.T.M Mobility Scooter
K
17
2440
Solax Electric Scooter, Models: S302121, S302131, S302141, S302151
K
17
2409
Lite
K
17
0634
Quingo Classic Power Scooter S1301, Quingo Flyte Power Scooter S551, Quingo Toura Power Scooter 5350
K
17
1256
Quingo Flyte Mobility Scooter
K
16
2952
C.T.M. Mobility Scooter
K
16
3201
KYMCO EQ10D Scooter
K
16
0835
Titan 3W
K
16
0909
ATTO Mobility Scooter
K
15
1656
HEARTWAY Power Mobility Scooter
K
15
0998
HEARTWAY Power Mobility Scooter
K
15
0987
HEARTWAY Power Mobility Scooter, BRIO S19
K
14
3557
SupaScoota Motorized vehicle
K
15
1944
Luggie Super
K
15
0086
Titan
K
14
2912
Merits Yoga Power Scooter, S542
K
14
2162
MERITS TRANSFORMER POWER SCOOTER, S941
K
13
3187
FREERIDER FR1, models FR1-13, FR1-15, FR1-17
K
13
2855
HEARTWAY POWER MOBILITY SCOOTER
K
13
1302
SOLAX
K
13
0940
KYMCO EQ20C SCOOTER
K
12
2749
PRESTIGE-MOBIE
K
11
0165
FREERIDER MODEL LUGGIE MODEL 168-4IT
K
10
3771
LOTUS BLAKE ESTEEM SCOOTER
K
11
0567
C.T.M. MOBILITY SCOOTER HS515(3W)
K
11
0395
C.T.M. MOBILITY SCOOTER - MODEL HS 118
K
10
2304
BREEZE C MODEL C (3W), BREEZE C (4W)
K
10
2361
ZIP'R4/ ZIP'R4 XTRA SCOOTER
K
10
2358
ZIP'R3/ ZIP'R3 XTRA SCOOTER
K
10
1507
AMIGO CLASSIC FD
K
10
1142
HEARTWAY LIGHTWEIGHT POWER MOBILITY SCOOTER, S34
K
10
1143
HEARTWAY POWER MOBILITY SCOOTER, S11
K
09
2650
HEARTWAY POWER MOBILITY SCOOTER, S12
K
09
2155
HEARTWAY POWER MOBILITY SCOOTER, S8
K
09
2154
HEARTWAY POWER MOBILITY SCOOTER, S9
K
09
2088
VICTORY XL 130 FOUR WHEEL SCOOTER, MODEL SC713
K
09
1418
C.T.M. MOBILITY SCOOTER, MODEL HS-628, INVACARE ORION
K
09
0735
C.T.M. MOBILITY SCOOTER, HS-528
K
09
1212
WU'S 3 WHEELED ELECTRICAL SCOOTER, WT-T3H
K
09
0966
AMIGO CATEGORY III FULL-SIZED REGULAR DUTY 3 WHEEL (310000) AND AMIGO CATEGORY V HEAVY DUTY 3 WHEEL (650000)
K
09
1113
MAXIMA V, THREE WHEEL SCOOTER, MODEL SC900V MAXIMA V, FOUR WHEEL SCOOTER, MODEL SC940V
K
09
0805
V10, THREE WHEEL SCOOTER, MODEL SC610V, V10, THREE WHEEL SCOOTER, MODEL SC610VPS, V10, FOUR WHEEL SCOOTER, MODEL SC710
K
09
0524
GO GO ELITE TRAVELER V THREE WHEEL SCOOTER, MODEL SC40EV
K
08
3303
LANDLEX, MODEL: 402X
K
08
2963
WU'S 4-WHEELED NEO SCOOTER, WT-M3A
K
08
2900
KYMCO FORU, MODEL EQ10
K
08
2901
KYMCO FORU, MODEL EQ20
K
08
1980
KYMCO FORU, MODEL EQ35
K
08
1133
KYMCO FORU, MODEL EQ40
K
08
0242
HEARTWAY POWER MOBILITY SCOOTER, PF7
K
08
0288
TRAVEL PAL FOUR WHEEL SCOOTER, MODEL MM114
K
07
3044
HEARTWAY POWER MOBILITY SCOOTER, MODEL PT7
K
07
2712
COMFORT ELECTRIC SCOOTER, LY-EW408
K
07
2630
FORU, MODEL EQ30
K
07
2337
WU'S 4-WHEELED NEO SCOOTER, MODEL WT-M4A
K
07
2165
VICTORY THREE WHEEL SCOOTER, MODEL: SC610
K
07
2104
HEARTWAY POWER MOBILITY SCOOTER, PF6
K
07
1949
VICTORY, 4 WHEEL SCOOTER / MODEL, # SC1740
K
07
1282
MODEL SEGAEGO 4D SCOOTER
K
07
1284
MODEL SEGAEGO 3D SCOOTER
K
07
1007
HEARTWAY LIGHTWEIGHT POWER MOBILITY SCOOTER, S33
K
07
0817
LERADOTECH SCOOTER, MODEL SB
K
07
0802
LERADOTECH, MODEL SC
K
07
0602
C.T.M. MOBILITY SCOOTER# HS-265
K
07
0493
HEARTWAY POWER TILT SEATING SYSTEM POWER CHAIR, P17RT
K
07
0603
C.T.M. MOBILITTY SCOOTER # HS-295
K
06
2646
RUIKE, MODEL 3411
K
07
0025
C.T.M. MOBILITY SCOOTER, MODEL HS-310
K
06
3196
LANDLEX, MODEL S403X
K
06
2645
RUIKE, MODEL 3431
K
06
2676
RUIKE, MODEL 3331
K
06
3030
COMFORT SCOOTER MODEL LY-EW406
K
06
3389
GO GO ELITE TRAVELLER PLUS 4 WHEEL SCOOTER, MODEL SC54
K
06
3162
GOLDEN LITEWAY
K
06
3032
COMFORT SCOOTER, MODEL LY-EW415
K
06
2790
WU'S 3-WHEELED NEO SCOOTER, MODEL WT-T3E
K
06
2160
GO GO MINI, MODEL SC30
K
06
1912
FUSION
K
06
0697
TRAVEL PAL (MM-111B) /MEGA MOTION
K
06
0068
AVANTICARE, MODEL SA4021
K
05
2204
THE ELITE - ULTRA-LIGHT, COMPACT PORTABLE SCOOTER
K
06
0042
LANDLEX, MODEL P100X
K
05
1028
BREEZE
K
05
2558
VCS, MODEL S4T
K
05
2673
KING I POWERED SCOOTER, MODEL CTL-11
K
05
2486
PROASIA, MODEL L4501
K
05
2378
PROASIA, MODEL L3402
K
05
1130
VCS S3Y
K
05
1473
LEARDO, AVANTICARE ELECTRICAL SCOOTERSM3021
K
05
1131
VCS S3T
K
05
1538
AVANTICARE, MODEL SA4022
K
05
0793
LANDLEX MODEL S400X
K
05
0507
SMARTECH, MODEL HOLI I
K
05
1116
MODEL TL-560 POWER SCOOTER
K
05
1118
MODEL TL-360 POWER SCOOTER
K
05
0792
LANDLEX, MODEL S300X
K
05
0042
WU'S 4-WHEELED NEO SCOOTER, WT-XL4
K
04
3326
BEWELL, MODEL SC 20
K
04
2104
AMERICAN BANTEX, MODEL MS 3
K
04
2764
MEDLINE STRIDER MIDI 4
K
04
2763
MODIFICATION TO MEDLINE STRIDER MIDI 3
K
04
2012
TEH LIN POWER SCOOTER, MODEL TL-822
K
04
2011
POWER SCOOTER, MODEL TL0821
K
04
2010
POWER SCOOTER, MODEL TL-688
K
04
1677
KARMA SCOOTER, MODEL KS-747.2
K
04
0754
AMERICAN BANTEX MS 4 MINI SCOOTER
K
04
1193
A&I SCOOTER, SC-402
K
04
1187
A&I SCOOTER, SC-301
K
04
1055
MEDLINE STRIDER MAXI 4
K
04
1054
MEDLINE STRIDER MAXI 3
K
04
1053
MEDLINE STRIDER MICRO 3
K
04
0838
MEDLINE STRIDER MINI 4
K
04
0818
MEDLINE STRIDER MINI 3
K
04
1025
BUZZAROUND, VEHICLE, MOTORIZED 3-WHEELED
K
04
0968
WU'S 4-WHEELED NEO SCOOTER, MODEL WT-T4D
K
03
3116
OPTI-RIDER DELUXE
K
04
0097
MEDLINE STRIDER MIDI 3
K
03
2446
MEDLINE STRIDER, MODELS MIDI 3 AND MIDI 4
K
03
3019
SUNPEX TECHNOLOGIES MODEL SE03
K
03
3240
BE-MOBILE 3-WHEELED ELECTRIC SCOOTER, MODEL DK S200
K
03
3220
BE-MOBILE 4-WHEELED ELECTRIC SCOOTER, MODEL DK S280
K
03
2645
JUSTWIN SCOOTER, JS-3014
K
03
2643
JUSTWIN SCOOTER, JS-3013
K
03
2488
WU'S 3-WHEELED NEO SCOOTER, WT-T3D
K
03
2879
NAVIGATOR I
K
03
3239
BE-MOBILE 4-WHEELED ELECTRIC SCOOTER, MODEL DK S500
K
03
3219
BE-MOBILE 4-WHEELED ELECTRIC SCOOTER, MODEL DK S600
K
03
3204
ESG 4-WHEEL SCOOTER, ESG-03
K
03
2617
WU'S 4-WHEELED SCOOTER, WT-L4JR
K
03
3241
BE-MOBILE 3-WHEELED ELECTRIC SCOOTER, MODEL DK S320
K
03
3032
WU'S 3-WHEELED NEO SCOOTER, MODEL WT-M3JR
K
03
2919
C.T.M. MOBILITY SCOOTER, MODEL HS-250
K
03
2918
C.T.M. MOBILITY SCOOTER, MODEL HS-235
K
03
0756
COACH 777-3
K
03
0757
COACH 777-4
K
03
2489
WU'S 4-WHEELED NEO SCOOTER, WT-M4JR
K
03
2277
JUSTWIN SCOOTER, MODEL JS-401
K
03
1897
PF-2 BATTERY OPERATED ELECTRIC FOUR WHEEL POWER SCOOTER
K
03
1315
TMC ELECTRICAL SCOOTER, EASY 321
K
03
1314
TMC ELECTRICAL SCOOTER, EASY 411
K
03
1313
TMC ELECTRICAL SCOOTER, EASY 405
K
03
1309
KUANN DAH, COOL TANK MOTORIZED SCOOTER, KS4L320
K
03
0758
COACH 888
K
03
1272
C.T.M. MOBILITY SCOOTER, MODEL HS-120
K
03
0759
LITTLE COACH
K
02
4325
JI-EE ELECTRIC SCOOTER, ESTHETE ES 1
K
02
4329
JI-EE ELECTRIC SCOOTER, ELEGANCE ES 3
K
03
0814
INVACARE ADVENTURE SERIES SCOOTERS, MODELS ADVENTURE SX-3 & LX-3
K
03
0387
C.T.M. MOBILITY SCOOTER, MODEL HS-890
K
02
3166
WU'S 3-WHEELED NEO SCOOTER, WT-M4
K
02
3168
WU'S 3-WHEELED NEO SCOOTER, WT-T3B
K
02
3040
WU'S 3-WHEELED NEO SCOOTER, WT-L3
K
02
3581
COMFORT AGILE SCOOTER, LY-EW303
K
02
2698
SCOOTER MARS SERIES, MODEL TL-588
K
02
2518
J.P. 3-WHEELED SCOOTER, ES-350 CITYBUG II/ RABBIT
K
02
1925
SUNPEX TECHNOLOGIES MODEL SE 01
K
02
2369
COMFORT WINDJOY SCOOTER, MODEL LY-EW302
K
02
1910
COMFORT DREAMRIDER SCOOTER, LY-EW402
K
01
3763
WU'S 4-WHEELED NEO SCOOTER, WT-L4
K
01
4119
WU'S 3-WHEELED NEO SCOOTER, WT-M3
K
02
1371
SUNSPEX TECHNOLOGIES MODEL SE 02
K
02
0002
MODEL P-33, BATTERY OPERATED, THREE WHEEL, POWER SCOOTER , MODEL P-33
K
02
0001
PF-3, BATTERY OPERATED, FOUR WHEEL, POWER SCOOTER, MODEL PF-3
K
01
3927
MINI SHOPPER
K
01
3788
TRAVEL EASE ELECTRIC SCOOTER, MODEL PIONEER 5
K
01
2258
COMPANION MODEL 221, 321, 421
K
01
1473
SNAZZY2
K
01
1476
SOVEREIGN
K
01
2792
C.T.M. MOBITIY SCOOTER MODEL #HS-360
K
01
2791
C.T.M. MOBILITY SCOOTER MODEL # HS-320
K
01
2592
EASYTRAVEL
K
01
1751
TRAVEL EASE ELECTRIC SCOOTER, MODEL PIONEER 3
K
01
1753
TRAVEL EASE ELECTRIC SCOOTER, MODEL PIONEER 4
K
01
1707
TRAVEL EASE ELECTRIC SCOOTER MODEL # PIONEER 2
K
01
1401
RAMBLER
K
01
0503
AMIGO WHEELCHAIR
K
01
1107
MODIFICATION TO SOLO
K
01
0606
SAFARI
K
00
3058
LASER 3 SPSC300
K
00
3059
LASER 4SPSC340
K
01
0135
MODELS LYNX AND PANTHER MOTORIZED SCOOTERS, MODELS LYNX SX-3, LYNX SX-3P, LYNX LX-3, LYNX LX-3, PANTHER LX-4
K
00
3815
TRAVEL EASE ELECTRIC SCOOTER, MODEL PIONEER
K
00
2616
ELECTRIC MOBILITY RASCAL AND CHAUFFER SCOOTERS
K
00
1835
IRV2000 INDIVIDUAL RECREATIONAL VEHICLE
K
00
0356
C.T.M. MOBILITY SCOOTER, MODEL H2-686, HS-740, HS-580
K
00
0354
C.T.M. MOBILITY SCOOTERS HS-666, HS-730, HS-570
K
00
0869
LA PERSONAL SCOOTER
K
98
4565
TMC-EASY-302
K
99
4127
GLORY
K
99
1281
ELECTRIC MOBILITY CAVALIER SCOOTERS
K
99
1132
ACTIVA
K
99
2052
MODELS LYNX AND PANTHER MOTORIZED SCOOTERS
K
98
3987
AMIGO MODEL 590000
K
98
2145
MEGA 3
K
98
2144
MEGA 4
K
98
3663
C.T.M. MOBILITY SCOOTER, MODEL # HS-666
K
98
3662
C.T.M. MOBILITY SCOOTER, MODEL # HS-686
K
98
1885
SUNRISE SCOOTER SERIES, MODEL UNASSIGNED, 3 WHEEL STANDARD MODEL, 3 WHEEL MID RANGE MODEL, 3 WHEEL HIGH END MODEL, 4 WHE
K
98
3405
ACEME JUPITER SCOOTER, 3-WHEELED, MODEL JUPITER 50
K
98
3407
ACEME JUPITER SCOOTER, 4-WHEELED,MODEL JUPITER 50F
K
98
1121
AMIGO RT
K
97
0646
SAFARI
K
97
1043
GOLDEN EAGLE
K
97
1050
GOLDEN HAWK
K
97
1388
FREERIDER, MODEL FR168-4
K
97
1387
FREERIDER, MODEL FR510-F
K
96
5123
PACE SAVER, LITTLE JUNIOR (MODIFICATION)(MOTORIZED THREE-WHEELED VEHICLE)
K
97
2036
STEALTH
K
97
2038
INTRUDER
K
97
2037
PROWLER
K
97
0523
SOLO
K
96
4954
SUPERLIGHT
K
96
2583
CAT SCOOTER WITH DS60 VONYTOLLRT
K
95
5274
BOOSTER LITE 3 MOTORIZED SCOOTER
K
95
5275
BOOSTER TROPHY 5 MOTORIZED SCOOTER
K
95
5276
BOOSTER LITE 4 MOTORIZED SCOOTER
K
96
1888
PILLAR 4-WHEEL SCOOTER
K
95
4378
FORMULA IV ELECTRIC MOBILITY VEHICLE
K
95
4974
PACE SAVER LITTLE JUNIOR (MODIFICATION)
K
95
2042
TRAVEL EASE ELECTRIC SCOOTER, MODEL: PIONEER
K
94
4940
EURO SC500
K
95
2112
AMIGO GRAND TOUR
K
94
4277
DYNAMO
K
94
4939
CELEBRITY XL SC445
K
94
2508
ROBO
K
94
0334
AMIGO J-9
K
94
1966
CAT SCOOTER
K
93
1231
SIDEKICK II
K
92
5122
PACE SAVER LITTLE JR
K
93
0952
PRIDE LEGEND SC-340
K
93
0953
CELEBRITY SC440
K
92
6499
SHUTTLE SC-140
K
92
6296
CELEBRITY SC400
K
92
6295
LEGEND SC 300
K
92
4515
ELECTRIC MOBILITY RASCAL
K
92
3796
BOBCAT
K
92
2967
FORTRESS 1700FS REAR WHEEL DRIVE SCOOTER
K
92
2966
FORTRESS 1704FS FOUR WHEEL SCOOTER
K
91
5416
FYMCO FLYER
K
92
3193
SUNRUNNER TE-777
K
92
2305
COYOTE ELECTRIC SCOOTER-3WHEELED
K
92
2304
ROADRUNNER ELECTRIC SCOOTER-3 WHEELED
K
92
2338
X-330/SPIRIT MOTORIZED THREE-WHEELED SCOOTER
K
92
1647
REGAL MOTORIZIED 3 WHEELED VEHICLE
K
92
1467
DRAKE & DRAKE/200 DL
K
92
1069
FORTRESS 1800FS REAR WHEEL DRIVE SCOOTER
K
92
0654
SHOPRIDER - TE889
K
91
5659
THREE WHEEL SCOOTER
K
91
3989
510 DL POWERED WHEELCHAIRS
K
91
0751
FORTRESS 1600ACV REAR WHEEL DRIVE SCOOTER
K
91
0265
TRAVELER, MOTORIZED THREE-WHEELED VEHICLE
K
90
5271
PRIDE SPIRIT
K
90
5245
SPORTS RIDER AND SHOP RIDER
K
90
4522
VARIOUS MODELS OF WHEELCHAIRS
K
90
1586
TRI-ROLLS REAR WHEEL DRIVE POWERED SCOOTER
K
90
0738
BOOSTER MOTORIZED THREE WHEELED VEHICLE
K
90
0600
TRI-SCOOT FRONT WHEEL DRIVE POWERED SCOOTER
K
90
0042
FORTRESS BUDDY FRONT WHEEL DRIVE SCOOTER
K
90
0041
FORTRESS LIBERATOR RWD SCOOTER
K
89
6025
THE SHUTTLE (TM) THREE WHEEL SCOOTER
K
89
5692
FORTRESS MODEL 2001LX ELECTRIC 3-WHEELER
K
89
5693
FORTRESS 2000FS 3-WHEEL SCOOTER
K
89
5694
FORTRESS MODEL 2200FS FRONT WHEEL DRIVE SCOOTER
K
89
4112
RAOMER
K
89
3429
ALPHA CONDOR
K
89
3248
ALPHA MALLARD
K
89
1609
CARRETTE 3 WHEELED MOTORIZED CART
K
88
1766
REM 250 THREE WHEELED ELECTRIC CART
K
88
0425
STERLING (MOTORIZED VEHICLE)
K
88
0424
SCOOTA BUG (MOTORIZED VEHICLE)
K
87
3500
MINI CROSSER BATTERY POWERED WHEELCHAIR
K
87
3609
VEHICLE, MOTORIZED (3-WHEELED ELECTRIC CART)
K
87
2518
REM500 THREE WHEELED ELEC. CART.
K
86
4686
SCOOTA MOTORIZED VEHICLE
K
85
3918
THE SPORTSTER (ELECTRIFIED WHEELCHAIR)
K
85
3766
ALPHA SUPER KART
K
85
2557
ALL TERRAIN AMIGO
K
85
2380
SPARROW MOTORIZED SCOOTER
K
85
1256
MOBIE SCOOTER
K
84
1919
ALPHA TRI-KART
K
84
0866
PORTASCOOT POWER SEAT
K
84
0196
MINI-BEEP
K
83
4506
PACESAVER & SCOUT
K
83
2727
MOBIE
K
83
0345
SCOOTER, VEHICLE MOTORIZED
K
82
2696
MASTER I
INK
Stretcher, Wheeled, Powered
INM
Chair, With Casters
INN
Chair, Adjustable, Mechanical
INO
Chair, Positioning, Electric
INP
Tips And Pads, Cane, Crutch And Walker
INQ
Table, Powered
INT
Plinth
INW
Table, Mechanical
IOR
Wheelchair, Mechanical
IOY
Support, Arm
IOZ
Splint, Abduction, Congenital Hip Dislocation
IPG
Shoe, Cast
IPL
Wheelchair, Standup
IPM
Cover, Limb
IPO
Orthosis, Pneumatic Structure, Rigid
IPR
Crutch
IPS
Cane
IPT
Orthosis, Thoracic
IPW
Orthosis, Sacroiliac, Soft
IPX
Orthosis, Rib Fracture, Soft
IPY
Orthosis, Lumbo-Sacral
IQA
System, Environmental Control, Powered
IQB
Belt, Wheelchair
IQC
Wheelchair, Special Grade
IQE
Orthosis, Lumbar
IQF
Orthosis, Cervical-Thoracic, Rigid
IQI
Orthosis, Limb Brace
IQJ
Splint, Clavicle
IQK
Orthosis, Cervical
IQM
Splint, Temporary Training
IQO
Device, Prosthesis Alignment
IQP
Rotator, Transverse
IQQ
Joint, Shoulder, External Limb Component
IQW
Hook, External Limb Component, Powered
IQX
Hook, External Limb Component, Mechanical
IQZ
Hand, External Limb Component, Powered
IRA
Hand, External Limb Component, Mechanical
IRD
Joint, Elbow, External Limb Component, Mechanical
IRE
Joint, Elbow, External Limb Component, Powered
ISH
Component, External, Limb, Ankle/Foot
ISL
Joint, Hip, External Limb Component
ISM
Pylon, Post Surgical
ISN
Cable
ISP
Valve, Prosthesis
ISR
Band Or Belt, Pelvic Support
ISS
Prosthesis, Thigh Socket, External Component
ISW
Assembly, Knee/Shank/Ankle/Foot, External
ISY
Joint, Knee, External Limb Component
ISZ
Unit, Wrist, External Limb Component, Mechanical
ITC
Stirrup, External Brace Component
ITG
Bandage, Cast
ITI
Wheelchair, Powered
ITJ
Walker, Mechanical
ITM
Cage, Knee
ITN
Splint, Denis Brown
ITO
Twister, Brace Setting
ITQ
Joint, Knee, External Brace
ITS
Joint, Hip, External Brace
ITW
Joint, Ankle, External Brace
KFT
Assembly, Shoulder/Elbow/Forearm/Wrist/Hand, Mechanical
KFW
Assembly, Shoulder/Elbow/Forearm/Wrist/Hand, Powered
KFX
Assembly, Thigh/Knee/Shank/Ankle/Foot, External
KGH
Unit, Wrist, External Limb Component, Powered
KHY
Cane, Safety Walk
KIC
Cushion, Flotation
KID
Restraint, Wheelchair, Non-Protective
KNN
Components, Wheelchair
KNO
Accessories, Wheelchair
KNP
Orthosis, Corrective Shoe
KTD
Orthosis, Abdominal
LBE
Stroller, Adaptive
LFF
Unit, Activation, Breath Control
MNE
Orthosis, Moldable, Supportive, Skin Protective
MRI
Orthosis, Truncal/Orthosis, Limb
NDA
Helmet, Cranial, For Protective Use
NHF
Monitor, Orthotic/Prosthetic
NJB
Orthosis, Truncal, For Dysmenorrhea
NXE
Walker, Mechanical, Poly Vinyl Chloride (Pvc)
OHI
Orthosis, Foot Drop
PAE
Upper Extremity Prosthesis With Multiple Simultaneous Degrees Of Freedom And Controlled Via Cutaneous Electromyography
PCE
Permanently Mounted Wheelchair Platform Lift
PMV
Orthosis, Limb, For Back Pain
QDT
Shoe With Adjustable Sole Units
Subpart E—Surgical Devices
Subpart F—Neurological Therapeutic Devices
Subpart F—Physical Medicine Therapeutic Devices
Radiology
General and Plastic Surgery
Toxicology
Medical Genetics
Unknown
PM
/
subpart-d—physical-medicine-prosthetic-devices
/
INI
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K024329
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JI-EE ELECTRIC SCOOTER, ELEGANCE ES 3
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K024329
510(k) Type
Traditional
Applicant
JI-EE INDUSTRY CO., LTD.
Country
Taiwan
FDA Decision
Substantially Equivalent
Decision Date
3/21/2003
Days to Decision
85 days
Submission Type
Statement