ASTROTILT MANUAL WHEELCHAIR

• K Number: K061475
• Device Name: ASTROTILT MANUAL WHEELCHAIR
• Manufacturer: PDG PRODUCT DESIGN GROUP, INC.
• Date Cleared: 2006-06-14 ( 15 days)
• Product Code: IOR
• Regulation Number: 890.3850
• Type: Traditional
• Panel: PM
• Reference & Predicate Devices: N/A

Intended Use

To provide mobility to individuals limited to a sitting position.

Device Description

Not Found

AI/ML Overview

This document is a 510(k) premarket notification letter from the FDA regarding a mechanical wheelchair. It does not contain information about the acceptance criteria or a study proving device performance as it pertains to a software algorithm or AI-driven medical device.

Therefore, I cannot provide the requested information based on the given text.

The document is a regulatory approval letter for a physical product (a manual wheelchair), not a description of a study for a diagnostic or AI-driven medical device. The typical information requested (e.g., sample sizes, ground truth, expert qualifications, MRMC studies) are specific to the evaluation of software or AI performance, which is not applicable here.

Regulation Number and Section

§ 890.3850 Mechanical wheelchair.

(a)
Identification. A mechanical wheelchair is a manually operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.(b)
Classification. Class I (general controls).