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510(k) Data Aggregation
K Number
K180852Device Name
Manual Wheelchair
Manufacturer
Date Cleared
2019-03-01
(333 days)
Product Code
Regulation Number
890.3850Why did this record match?
Applicant Name (Manufacturer) :
Jiangyin Newrise Medical Equipment 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, Manual Wheelchair model XSG106A, 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, the materials meet the standard of ASTM B107M-2012, and 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 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.
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