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..

355

Total

355

Cleared

119d

Avg days

1982

Since

355 devices

265–288 of 355

Cleared Dec 18, 1998

C.T.M. MOBILITY SCOOTER, MODEL # HS-686

Warepalmy Enterprise, LLC (Usa)

Physical Medicine · 60d

Cleared Dec 18, 1998

C.T.M. MOBILITY SCOOTER, MODEL # HS-666

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

Sunrise Medical, Inc.

Physical Medicine · 167d

Cleared Nov 06, 1998

ACEME JUPITER SCOOTER, 3-WHEELED, MODEL JUPITER 50

Aceme Technologies Intl.

Physical Medicine · 39d

Cleared Nov 06, 1998

ACEME JUPITER SCOOTER, 4-WHEELED,MODEL JUPITER 50F

Aceme Technologies Intl.

Physical Medicine · 39d

Cleared Jun 30, 1998

Amigo Mobility Intl., Inc.

Physical Medicine · 95d

Cleared Aug 25, 1997

Ranger All Season Corp.

Physical Medicine · 195d

Cleared Aug 01, 1997

Golden Technologies, Inc.

Physical Medicine · 133d

Cleared Aug 01, 1997

Golden Technologies, Inc.

Physical Medicine · 133d

Cleared Jul 23, 1997

FREERIDER, MODEL FR510-F

Freerider USA, Inc.

Physical Medicine · 100d

Cleared Jul 23, 1997

FREERIDER, MODEL FR168-4

Freerider USA, Inc.

Physical Medicine · 100d

Cleared Jul 17, 1997

PACE SAVER, LITTLE JUNIOR (MODIFICATION)(MOTORIZED THREE-WHEELED VEHICLE)

Physical Medicine · 244d

Cleared Jul 03, 1997

The Buzzz Corp.

Physical Medicine · 31d

Cleared Jul 03, 1997

The Buzzz Corp.

Physical Medicine · 31d

Cleared Jul 03, 1997

The Buzzz Corp.

Physical Medicine · 31d

Cleared Jun 03, 1997

Ranger All Season Corp.

Physical Medicine · 112d

Cleared Mar 20, 1997

Wheelcare Scooters, Inc.

Physical Medicine · 99d

Cleared Dec 18, 1996

CAT SCOOTER WITH DS60 VONYTOLLRT

Invacare Respiratory Corp.

Physical Medicine · 170d

Cleared Nov 04, 1996

BOOSTER LITE 3 MOTORIZED SCOOTER

Optimed Technologies, Inc.

Physical Medicine · 355d

Cleared Nov 04, 1996

BOOSTER TROPHY 5 MOTORIZED SCOOTER

Optimed Technologies, Inc.

Physical Medicine · 355d

Cleared Nov 04, 1996

BOOSTER LITE 4 MOTORIZED SCOOTER

Optimed Technologies, Inc.

Physical Medicine · 355d

Cleared Oct 23, 1996

PILLAR 4-WHEEL SCOOTER

Pillar Technology, Inc.

Physical Medicine · 161d

Cleared Jul 25, 1996

FORMULA IV ELECTRIC MOBILITY VEHICLE

Physical Medicine · 310d

Cleared Mar 19, 1996

PACE SAVER LITTLE JUNIOR (MODIFICATION)

Burke Mobility Products

Physical Medicine · 146d