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510(k) Data Aggregation
K Number
K163352Device Name
Wheelchair
Manufacturer
Date Cleared
2017-07-28
(240 days)
Product Code
Regulation Number
890.3850Why did this record match?
Applicant Name (Manufacturer) :
Kunshan Hi-Fortune Health Products Co.,Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The device is intended for medical purposes to provide mobility to persons restricted to a sitting position.
Device Description
The proposed device, Wheelchair model HM303, is traditional manually operated, user propelled, manual, mechanical wheelchairs. The device can be foldable easily for transport.
The main frame is made of magnesium alloy frame, which has a seat base with four-wheeled with a back cover. Upon the outside of this framework, and to the rear, are assembled two axle plates, wheels are connected to the stainless steel axle receivers via stainless steel axles. On the front end of the frame are assembled two caster housings. Caster forks are mounted to these housings via steel axles. On the front end of the frame, upon the caster, two footplates are assembled for foot holding. Two armrests are mounted on the frame for user's arm holding. Two grips mounted on the top end of the frame with a brake, and another brake is designed under the seat base. A folden set is on the frame, under the grips, for folding backrest.
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