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510(k) Data Aggregation
K Number
K973418Device Name
UNIVERSAL/1000 SERIES(101S101SDU1100)/ROLLS 2000(2000E)/TRANSPORT(M4)
Manufacturer
Date Cleared
1997-10-09
(29 days)
Product Code
Regulation Number
890.3850Why did this record match?
Applicant Name (Manufacturer) :
ASSEMBLY REQUIRED DIST., INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Predicate manual wheelchair use is stated to allow user, or user assistant to propel or push chair in order to maneuver seated individual in a safe, controlled environment. Also must be able to lock rear wheels for patient transfer. Subject wheelchair is to have same functionality.
Device Description
Wheelchair to be a manual transport device, with 8" fron swivel casters on the front, and 24" mag style wheels on the rear. Wheelchair will be foldable for storage, will be chrom- plate Finnish. Armrests will be padded or plastic and wil have padded embossed upholstery for user comfort. Wheelchair will be equipped with wheel locks to prevent rolling while transferring patient. Push handles will be of a non-slip vinyl material. Standard color available will be dark blue. Chairs to have rear extensions to prevent tip-over. Wheelchairs to be available in models with swing away footrests or elevating legrests as shown in pictures.
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