LogoFDA 510(k) Search
K Number
K993032
Device Name
MODIFICATION TO MP-3 POWER BASE CHAIR
Manufacturer
MERITS HEALTH PRODUCTS., INC.
Date Cleared
1999-11-05

(87 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

Merits Health Products MP3 is a handicap piece of equipment and it is used to assist disabled people to negotiate their daily living. People with muscular disease use this chair to improve their daily living.

Device Description

MP-3 Power Base Chair

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for a medical device (MP-3 Power Base Chair) and does not contain information about acceptance criteria or a study proving device performance against such criteria. The letter confirms substantial equivalence to a predicate device and provides regulatory guidance for marketing.

Therefore, I cannot provide the requested information.

§ 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).