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K Number
K021199
Device Name
PRIMECHAIR
Manufacturer
DALTON MEDICAL CORP.
Date Cleared
2002-07-12

(87 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 intended use of the eLexus is to provide mobility to persons limited to a seated position that are capable of operating a powered wheelchair.

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text does not contain the information requested to answer the prompt. The document is an FDA 510(k) clearance letter for a powered wheelchair called "Primechair" (later corrected to "eLexus"). It discusses the regulatory approval process but does not include any details about acceptance criteria, device performance studies, sample sizes, expert qualifications, ground truth, or multi-reader multi-case studies.

§ 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).