LogoFDA 510(k) Search
K Number
K982066
Device Name
MP-3 POWER BASE CHAIR
Manufacturer
MERITS HEALTH PRODUCTS., INC.
Date Cleared
1998-08-31

(81 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 Merits MP-3 power base wheelchair will be used by handicapped people who are unable to ambulate. People who cannot ambulate and have weak upper body strength and cannot propel a manual wheelchair will be the ones who will benefit from the use of the MP-3 power base wheelchair.

Device Description

MP-3 Power Base Chair

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for a power base chair (MP-3 Power Base Chair). It does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or any other details related to the efficacy or safety testing of the device.

The letter only states that the device is substantially equivalent to legally marketed predicate devices and can therefore be marketed.

Therefore, I cannot provide the requested information based on the input 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).