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510(k) Data Aggregation
K Number
K220671Device Name
Manual Wheelchair
Date Cleared
2022-07-21
(136 days)
Product Code
Regulation Number
890.3850Why did this record match?
Applicant Name (Manufacturer) :
Hebei Ruilangde Medical Equipment Technology Group Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Manual Wheelchair is intended for medical purposes to provide mobility to persons restricted to a sitting position.
Device Description
The Manual Wheelchair is a wheeled personal mobility device that incorporates a seat-support system for a person with a disability or a person without the full capacity to walk designed to be manually propelled by the user while seated in the device or by an attendant. The occupant moves the wheelchair by rotating two handrims protruding from rear wheels. An attendant moves the device by pushing or pulling handles on the device. The device can be folded for transport. The device can be operated indoor or outdoor on dry, smooth surfaces composed of concrete, blacktop or asphalt under normal driving conditions. The subject manual wheelchair is a mechanical wheelchair with four wheels, including two front casters and two rear wheels, a frame made of carbon steel, a seat and a backrest made of oxford fabric, which is soft and water-resistant, two handles, armrests, handrims, foot pedals, legrest strap and seat belt. The subject manual wheelchair has a physical dimension of 1085mm × 700mm ×935mm (length × width × height). The device has a weight capacity of 100 kilograms, and its total mass is 17.3kg. The color is black.
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