START FAMILY OF MANUAL WHEELCHAIRS (BASIC, PLUS, MULTI AND HEMI)

• K Number: K052681
• Device Name: START FAMILY OF MANUAL WHEELCHAIRS (BASIC, PLUS, MULTI AND HEMI)
• Manufacturer: OTTO BOCK HEALTH CARE, LP
• Date Cleared: 2005-10-06 ( 8 days)
• Product Code: IOR
• Regulation Number: 890.3850
• Type: Traditional
• Panel: PM
• Reference & Predicate Devices: N/A

Intended Use

Persons who are unable to walk or who have a walking impediment.

Device Description

Not Found

AI/ML Overview

The provided text is a 510(k) summary for a manual wheelchair, which is a physical device, not a digital health device or an AI/ML-driven device. As such, it does not contain the information required to answer the questions about acceptance criteria, study details, ground truth, or AI/ML performance.

Therefore, I cannot extract the requested information from this document.

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).