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K Number
K033142
Device Name
POWERED WHEELCHAIR
Manufacturer
NATS CORP.
Date Cleared
2004-05-19

(232 days)

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

The Powered Wheelchair is intended for use to provide mobility to The Towered "Whoolonal" is "the capability of operating a power wheelchair.

Device Description

Powered Wheelchair

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for a Powered Wheelchair. It is a regulatory approval document and does not contain any information regarding acceptance criteria or the study data that proves the device meets those criteria, as typically found for AI/ML devices.

Therefore, I cannot extract the requested information from the provided text. The document itself is the clearance, not the detailed technical data that led to the clearance.

§ 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).