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K Number
K022696
Device Name
TEH LIN POWERED WHEELCHAIR, MODEL MDG-201
Manufacturer
TEH LIN PROSTHETIC & ORTHOPAEDIC, INC.
Date Cleared
2003-02-07

(178 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 device is intended for medical purposes to provide mobility to persons restricted to a sitting position.

Device Description

Not Found

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for a powered wheelchair. It does not contain information about acceptance criteria or a study that proves the device meets acceptance criteria. The letter confirms that the device, "The Lin Powered Wheelchair, Model MDG-201," is substantially equivalent to legally marketed predicate devices. This means that its safety and effectiveness are considered to be similar to other devices already on the market, but it does not detail specific performance studies or acceptance criteria beyond regulatory compliance.

§ 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).