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510(k) Data Aggregation
K Number
K191356Device Name
i3 Foldable Mobility Scooter
Manufacturer
PUC Perfect Union Co., LTD.
Date Cleared
2022-01-11
(966 days)
Product Code
INI
Regulation Number
890.3800Why did this record match?
Applicant Name (Manufacturer) :
PUC Perfect Union Co., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The device is intended for medical purposes to provide mobility to persons restricted to a sitting position.
Device Description
The device "i3" is an indoor/outdoor use mobility scooter that is intended to be used by a person who is able to walk but still with "minor mobility problems." The mobility scooter "i3" is composed of metal alloy frame, two front wheels, two rear wheels, two anti-tip wheels, a speed control throttle lever for high/low speed adjustment, a upper control console with a battery indicator, a horn, a key, and a speed control dial, a Li-ion battery with an off-board charger, a motor/electromagnetic brake assembly, an electric motor controller, and a seat/backrest set. The overall dimension of the scooter is L1014*W468*H981 mm. The total weight of the scooter is 25 kg without battery inside. It can easily be folded and unfolded for transportation in a car boot. The maximum weight capacity of "i3" is 300 lbs. (Approx.136 kg), and its maximum speed is allowed 4 mph (Approx. 6 km/h).
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