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K Number
K123975
Device Name
QUICKIE & ZIPPIE SERIES
Manufacturer
SUNRISE MEDICAL
Date Cleared
2013-08-16

(233 days)

Product Code
IOR
Regulation Number
890.3850
Type
Traditional
Panel
PM
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Sunrise Medical Zippie and Quickie Series Wheelchairs are intended to provide mobility to persons limited to a sitting position.

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text does not contain information about the acceptance criteria or a study proving that a device meets those criteria. The document is an FDA 510(k) clearance letter for various models of wheelchairs, confirming their substantial equivalence to predicate devices and outlining regulatory requirements. It does not include details on performance metrics, study designs, sample sizes, expert qualifications, or ground truth establishment relevant to the request.

§ 890.3850 Mechanical wheelchair.

(a)
Identification. A mechanical wheelchair is a manually operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.(b)
Classification. Class I (general controls).