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510(k) Data Aggregation
K Number
K040561Device Name
MANUAL WHEELCHAIR SERIES
Manufacturer
Date Cleared
2004-03-31
(28 days)
Product Code
Regulation Number
890.3850Why did this record match?
Applicant Name (Manufacturer) :
SHANGHAI WHEELCHAIR FACTORY
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The intended use of the Manual Wheelchair Series is to provide mobility to persons limited to a sitting position.
Device Description
The Manual Wheelchair Series are manually operated, self or attendant propelled, manual, mechanical wheelchairs. Their intended function and use is to provide mobility to persons limited to a sitting position. The products may also be used as attendant propelled patient transport devices in a health care environment such as hospital, nursing homes, or extended care facilities.
The products consist primarily of a metal frame, large rear wheels with hand rims for propelling the chair, and smaller front pivoting casters for steering and turning. There is also an attendant propelled version (Model 0400), which has smaller rear wheels than the others in the series.
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