Solax Powered Wheelchair (Models: S7101, S7103)

• K Number: K182400
• Device Name: Solax Powered Wheelchair (Models: S7101, S7103)
• Manufacturer: Dongguan Prestige Sporting Goods Co., Ltd
• Date Cleared: 2020-04-14 ( 588 days)
• Product Code: ITI
• Regulation Number: 890.3860
• Type: Traditional
• Panel: PM
• Reference & Predicate Devices: N/A

Intended Use

The Solax Powered Wheelchair is a motor driven, indoor transportation vehicle with the intended use to provide mobility to a disabled or elderly person limited to a seated position.

Device Description

Not Found

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for a powered wheelchair, specifically the Solax Powered Wheelchair (Models: S7101, S7103). It confirms that the device is substantially equivalent to legally marketed predicate devices.

However, the provided text does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or comparative effectiveness studies (MRMC or standalone) for an AI/CAD product.

This document is purely an administrative FDA clearance for a physical medical device (a powered wheelchair), and therefore none of the requested information about AI/CAD validation studies is present.

Regulation Number and Section

§ 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).