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510(k) Data Aggregation
K Number
K200135Device Name
RGK Daily Range Wheelchairs
Manufacturer
Date Cleared
2020-09-10
(233 days)
Product Code
Regulation Number
890.3850Why did this record match?
Applicant Name (Manufacturer) :
RGK Wheelchairs, Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The RGK Daily Range Wheelchairs are mechanical wheels that are turned manually and allows mobility to physically handicapped persons restricted to a sitting position and capable of manually causing the wheels to turn.
Device Description
The RGK Daily Range Wheelchairs are mechanical wheelchairs that include four wheels, an aluminum or titanium frame, and a black nylon upholstery that is flame resistant. Each wheelchair includes multiple components such as wheels, castors, sideguards, footplates and wheel locks.
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