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510(k) Data Aggregation
K Number
K151797Device Name
Nuocande Plastic Manual Wheelchair Model NKD L07
Manufacturer
Date Cleared
2015-08-25
(54 days)
Product Code
Regulation Number
890.3850Why did this record match?
Applicant Name (Manufacturer) :
NINGBO LECOUNT MEDICAL TECHNOLOGY 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. It is designed for use indoors, and outdoors, over smooth surfaces (all standard indoor flooring surfaces, concrete, asphalt and pocked dirt) that are free of large obstacles and inclines greater than 5 degrees.
Device Description
A mechanical wheelchair is a chair with wheels, designed to be a replacement for walking, where it is propelled by the seated occupant turning the rear wheels by hand. There are also handles behind the seat for someone else to do the pushing. Wheelchairs are used by people for whom walking is difficult or impossible due to illness, injury, or disability.
"Nuocande Plastic Manual Wheelchair Model NKD L07" is user propelled, manually operated folding wheelchairs that are indicated for use indoors and outdoors, over smooth surfaces (all standard indoor flooring surfaces, concrete, asphalt and pocked dirt) that are free of large obstacles and inclines greater than 5 degrees. Each consists of four wheels, a mechanical frame and nylon upholstery that is ignition resistant.
"Nuocande Plastic Manual Wheelchair Model NKD L07" has a physical dimension of a physical dimension of 1090 (depth) x 730 (width) x 850 (height) mm, with the seat itself has a dimension of 411 (depth) x 447 (width) x 365 (height) mm. The device has a weight capacity of 100 kilograms, and weighs about 19 kilograms. The color is dark yellow.
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