INI · Class II · 21 CFR 890.3800

FDA Product Code INI: Vehicle, Motorized 3-wheeled

Three-wheeled motorized vehicles provide enhanced outdoor mobility for people with physical disabilities. FDA product code INI covers motorized three-wheeled mobility vehicles cleared as medical devices.

These scooter-style devices use a battery-powered motor and tiller steering to provide independent mobility for individuals who can sit upright but cannot walk distances. They offer greater stability on uneven terrain than four-wheeled scooters due to their turning radius.

INI devices are Class II medical devices, regulated under 21 CFR 890.3800 and reviewed by the FDA Physical Medicine panel.

Leading manufacturers include Wu'S Tech Co., Ltd., Heartway Medical Products Co., Ltd. and Pride Health Care, Inc..

351
Total
351
Cleared
119d
Avg days
1982
Since
351 devices
145–168 of 351
Cleared Jul 30, 2002
WU'S 4-WHEELED NEO SCOOTER, WT-L4
K013763
Wu'S Tech Co., Ltd.
Physical Medicine · 259d
Cleared Jul 25, 2002
WU'S 3-WHEELED NEO SCOOTER, WT-M3
K014119
Wu'S Tech Co., Ltd.
Physical Medicine · 220d
Cleared Dec 11, 2001
TRAVEL EASE ELECTRIC SCOOTER, MODEL PIONEER 5
K013788
Merits Health Products Co., Ltd.
Physical Medicine · 27d
Cleared Mar 08, 2001
LASER 3 SPSC300
K003058
Pride Mobility Products Corp.
Physical Medicine · 157d
Cleared Mar 01, 2001
LASER 4SPSC340
K003059
Pride Mobility Products Corp.
Physical Medicine · 150d
Cleared Feb 16, 2001
MODELS LYNX AND PANTHER MOTORIZED SCOOTERS, MODELS LYNX SX-3, LYNX SX-3P, LYNX LX-3, LYNX LX-3, PANTHER LX-4
K010135
Invacare Corp.
Physical Medicine · 30d
Cleared Feb 16, 2000
TMC-EASY-302
K984565
Tmc Magnetics & Machinery Corp.
Physical Medicine · 420d
Cleared Feb 03, 2000
GLORY
K994127
Pillar Technology, Inc.
Physical Medicine · 58d
Cleared Oct 27, 1999
ELECTRIC MOBILITY CAVALIER SCOOTERS
K991281
Electric Mobility Corp.
Physical Medicine · 196d
Cleared Oct 20, 1999
ACTIVA
K991132
Hoveround Corp.
Physical Medicine · 201d
Cleared Aug 12, 1999
MODELS LYNX AND PANTHER MOTORIZED SCOOTERS
K992052
Invacare Corp.
Physical Medicine · 55d
Cleared Jun 08, 1999
AMIGO MODEL 590000
K983987
Amigo Mobility Intl., Inc.
Physical Medicine · 211d
Cleared Apr 14, 1999
MEGA 4
K982144
Mega Motion, Inc.
Physical Medicine · 301d
Cleared Apr 14, 1999
MEGA 3
K982145
Mega Motion, Inc.
Physical Medicine · 301d
Cleared Dec 18, 1998
C.T.M. MOBILITY SCOOTER, MODEL # HS-686
K983662
Warepalmy Enterprise, LLC (Usa)
Physical Medicine · 60d
Cleared Dec 18, 1998
C.T.M. MOBILITY SCOOTER, MODEL # HS-666
K983663
Warepalmy Enterprise, LLC (Usa)
Physical Medicine · 60d
Cleared Nov 12, 1998
SUNRISE SCOOTER SERIES, MODEL UNASSIGNED, 3 WHEEL STANDARD MODEL, 3 WHEEL MID RANGE MODEL, 3 WHEEL HIGH END MODEL, 4 WHE
K981885
Sunrise Medical, Inc.
Physical Medicine · 167d
Cleared Nov 06, 1998
ACEME JUPITER SCOOTER, 3-WHEELED, MODEL JUPITER 50
K983405
Aceme Technologies Intl.
Physical Medicine · 39d
Cleared Nov 06, 1998
ACEME JUPITER SCOOTER, 4-WHEELED,MODEL JUPITER 50F
K983407
Aceme Technologies Intl.
Physical Medicine · 39d
Cleared Jun 30, 1998
AMIGO RT
K981121
Amigo Mobility Intl., Inc.
Physical Medicine · 95d
Cleared Aug 25, 1997
SAFARI
K970646
Ranger All Season Corp.
Physical Medicine · 195d
Cleared Aug 01, 1997
GOLDEN EAGLE
K971043
Golden Technologies, Inc.
Physical Medicine · 133d
Cleared Aug 01, 1997
GOLDEN HAWK
K971050
Golden Technologies, Inc.
Physical Medicine · 133d
Cleared Jul 23, 1997
FREERIDER, MODEL FR510-F
K971387
Freerider USA, Inc.
Physical Medicine · 100d