FDA Device Intelligence
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Vehicle, Motorized 3-Wheeled

FDA product code INI · Class 2 · Physical Medicine

520
Registered devices
2,715
Adverse events
22
Recalls
351
510(k) clearances

Devices with this code

Recent recalls

DateFirmReason
2021-04-01Merits Holdings Co. dba Merits Health Products, Inc.Seat baseplate pin has broken in the field.
2014-01-21Golden Technologies, Inc.Buzzaround XL scooters' front to rear lockup can become unintentionally disengaged due to possible improper fit of the front alignment cup to the rear alignment
2013-09-27S.A.E. AFIKIMBreeze C Scooter, motorized 3-wheeled electric scooter for elderly people, is recalled because it may become unresponsive during operation due to an electrical
2011-12-07Invacare CorporationInvacare Corporation decided to recall the products because the scooter backrest fails unexpectedly due to seat flexing, and this has the potential to result in
2011-06-22Pride Mobility Products CorpContract manufacturer error. Component part(s) (fuses) specifications were not adhered to as outlined in Pride's Engineering drawings.
2011-06-22Pride Mobility Products CorpContract manufacturer error. Component part(s) (fuses) specifications were not adhered to as outlined in Pride's Engineering drawings.
2010-11-26Pride Mobility Products CorpThe main harness connector was manufactured without the required back shield sealing protection. As a result, there is the potential for water to seep through t
2010-09-27Electric Mobility CorpScooter seat bases were found to have insufficient welding which may lead to the seat base becoming loose and causing the seat to wobble. This may result in com
2010-09-27Electric Mobility CorpScooter seat bases were found to have insufficient welding which may lead to the seat base becoming loose and causing the seat to wobble. This may result in com
2010-09-27Electric Mobility CorpScooter seat bases were found to have insufficient welding which may lead to the seat base becoming loose and causing the seat to wobble. This may result in com

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.