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

217–240 of 355

Cleared Mar 20, 2003

INVACARE ADVENTURE SERIES SCOOTERS, MODELS ADVENTURE SX-3 & LX-3

Physical Medicine · 6d

Cleared Mar 11, 2003

C.T.M. MOBILITY SCOOTER, MODEL HS-890

C.T.M. Homecare Product, Inc.

Physical Medicine · 34d

Cleared Jan 24, 2003

WU'S 3-WHEELED NEO SCOOTER, WT-L3

Wu'S Tech Co., Ltd.

Physical Medicine · 134d

Cleared Jan 24, 2003

WU'S 3-WHEELED NEO SCOOTER, WT-M4

Wu'S Tech Co., Ltd.

Physical Medicine · 123d

Cleared Jan 24, 2003

WU'S 3-WHEELED NEO SCOOTER, WT-T3B

Wu'S Tech Co., Ltd.

Physical Medicine · 123d

Cleared Dec 02, 2002

J.P. 3-WHEELED SCOOTER, ES-350 CITYBUG II/ RABBIT

Roc Chinese-European Industrial Research Society

Physical Medicine · 125d

Cleared Dec 02, 2002

SCOOTER MARS SERIES, MODEL TL-588

Teh Lin Prosthetic & Orthopaedic, Inc.

Physical Medicine · 111d

Cleared Dec 02, 2002

COMFORT AGILE SCOOTER, LY-EW303

Comfort Orthopedic Co., Ltd.

Physical Medicine · 39d

Cleared Nov 08, 2002

SUNPEX TECHNOLOGIES MODEL SE 01

Sunpex Technology Co., Ltd.

Physical Medicine · 150d

Cleared Oct 11, 2002

COMFORT DREAMRIDER SCOOTER, LY-EW402

Comfort Orthopedic Co., Ltd.

Physical Medicine · 123d

Cleared Oct 11, 2002

COMFORT WINDJOY SCOOTER, MODEL LY-EW302

Comfort Orthopedic Co., Ltd.

Physical Medicine · 81d

Cleared Jul 30, 2002

WU'S 4-WHEELED NEO SCOOTER, WT-L4

Wu'S Tech Co., Ltd.

Physical Medicine · 259d

Cleared Jul 25, 2002

WU'S 3-WHEELED NEO SCOOTER, WT-M3

Wu'S Tech Co., Ltd.

Physical Medicine · 220d

Cleared May 16, 2002

SUNSPEX TECHNOLOGIES MODEL SE 02

Sunpex Technology Co., Ltd.

Physical Medicine · 16d

Cleared Mar 21, 2002

PF-3, BATTERY OPERATED, FOUR WHEEL, POWER SCOOTER, MODEL PF-3

Transworld Mobility Distribution, LLC

Physical Medicine · 78d

Cleared Mar 21, 2002

MODEL P-33, BATTERY OPERATED, THREE WHEEL, POWER SCOOTER , MODEL P-33

Transworld Mobility Distribution, LLC

Physical Medicine · 78d

Cleared Jan 28, 2002

Shoprider Intl., Inc.

Physical Medicine · 61d

Cleared Dec 11, 2001

TRAVEL EASE ELECTRIC SCOOTER, MODEL PIONEER 5

Merits Health Products Co., Ltd.

Physical Medicine · 27d

Cleared Dec 03, 2001

COMPANION MODEL 221, 321, 421

Golden Technologies, Inc.

Physical Medicine · 138d

Cleared Nov 16, 2001

Shoprider Intl., Inc.

Physical Medicine · 186d

Cleared Oct 30, 2001

Shoprider Intl., Inc.

Physical Medicine · 169d

Cleared Oct 24, 2001

C.T.M. MOBILITY SCOOTER MODEL # HS-320

Warepalmy Enterprise, LLC (Usa)

Physical Medicine · 65d

Cleared Oct 24, 2001

C.T.M. MOBITIY SCOOTER MODEL #HS-360

Warepalmy Enterprise, LLC (Usa)

Physical Medicine · 65d

Cleared Oct 03, 2001

Tzora Active Systems , Ltd.

Physical Medicine · 54d