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K Number
K990484
Device Name
INDEPENDENCE 324
Manufacturer
EAGLE PARTS & PRODUCTS, INC.
Date Cleared
1999-06-25

(129 days)

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

THE INDEPENDENCE 324 IS INTENDED TO AID IN THE TEMPORARY OR PERMANENTLY MOBILITY IMPAIRED INDIVIDUAL TO MOVE ABOUT INDOORS, AND OUTDOORS, THROUGH THE USE OF A BATTERY POWERED, MOTORIZED THREE-WHEELED VEHICLE. THE WEIGHT CAPACITY OF THE INDIVIDUAL IS NOT TO EXCEED 300 LBS.

Device Description

Not Found

AI/ML Overview

This is an FDA premarket notification (510(k)) letter for the "INDEPENDENCE 324" and "INDEPENDENCE 624" devices. This document does not contain information regarding acceptance criteria, performance studies, sample sizes, ground truth establishment, or expert qualifications. It is a regulatory clearance letter indicating that the FDA has found the devices substantially equivalent to previously marketed devices.

Therefore, I cannot provide the requested information based on this document.

§ 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).