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K Number
K032441
Device Name
F-10 FOLDING POWER CHAIR
Manufacturer
WHEELCHAIR & SCOOTER EXPRESS
Date Cleared
2003-10-06

(60 days)

Product Code
ITI
Regulation Number
890.3860
Type
Traditional
Panel
Physical Medicine
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

To provide an optional means of mobility for physically challenged people.

Device Description

F-10 Folding Power Chair

AI/ML Overview

This is a 510(k) premarket notification for a medical device (F-10 Folding Power Chair), which is a regulatory submission to demonstrate substantial equivalence to a predicate device. It is not a study report demonstrating the device meets specific acceptance criteria based on performance metrics such as sensitivity or specificity.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, and ground truth establishment is not present in the provided document. The document primarily focuses on the regulatory approval process and the determination of substantial equivalence for the powered wheelchair to a legally marketed predicate device.

§ 890.3860 Powered wheelchair.

(a)
Identification. A powered wheelchair is a battery-operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.(b)
Classification. Class II (performance standards).