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K Number
K200978
Device Name
Electric Wheelchair (Model: S7110)
Manufacturer
Dongguan Prestige Sporting Goods Co., Ltd.
Date Cleared
2021-04-16

(368 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 Electric wheelchair (Model: S7110) is a motor driven, indoor transportation vehicle with the intended use to provide mobility to a disabled or elderly limited to a seated position.

Device Description

Not Found

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for an "Electric Wheelchair (Model: S7110)". It confirms that the device is substantially equivalent to legally marketed predicate devices.

The letter does not contain information about acceptance criteria, a specific study proving device performance against acceptance criteria, sample sizes, data provenance, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone algorithm performance, or ground truth details.

The document primarily addresses the regulatory approval process and includes the Indications for Use statement for the electric wheelchair.

§ 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).