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510(k) Data Aggregation
K Number
K122749Device Name
PRESTIGE-MOBIE
Manufacturer
PRESTIGE SPORTING GOODS CO. LTD.
Date Cleared
2012-12-27
(111 days)
Product Code
INI
Regulation Number
890.3800Why did this record match?
Applicant Name (Manufacturer) :
PRESTIGE SPORTING GOODS CO. LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The device is a motor driven, indoor and outdoor transportation vehicle with the intended use to provide mobility to a disabled or elderly person limited to a seated position.
Device Description
The MOBIE scooter consists of a foldable platform which connects the two front wheels and two rear wheels, an adjustable tiller, a Li-ion battery with an off-board charger, a motor/electromagnetic brake assembly, a electric motor controller and a seat /backrest set. It can be folded for transport in a car trunk. The patient uses the tiller handle/handlebar for steering and a thumb operated potentiometer throttle control lever located at the top of the tiller to engage and disengage the scooter motion in both the forward and reverse directions. When the throttle control lever is released, the electromagnetic brake will be actuated and the scooter is slow to stop.
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