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K Number
K990122
Device Name
INDEPENDENCE 624
Manufacturer
EAGLE PARTS & PRODUCTS, INC.
Date Cleared
1999-06-25

(163 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 temp permanently mobility impaired individual to move about in doors, and out through the use of a battery powere wheeled device. Weight capacity individual not to exceed 250 l

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text is a 510(k) clearance letter from the FDA, and it does not contain any information regarding device acceptance criteria, study data, or performance metrics. It simply states that the devices (Independence 624 and Independence 324) are substantially equivalent to previously marketed devices.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets those criteria, as this information is not present in the provided 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).