BIOTECH B990K VIVI WHEELCHAIR

• K Number: K014198
• Device Name: BIOTECH B990K VIVI WHEELCHAIR
• Manufacturer: TAIWAN ARMADA ENTERPRISE CO., LTD.
• Date Cleared: 2002-02-01 ( 42 days)
• Product Code: IOR
• Regulation Number: 890.3850
• Type: Traditional
• Panel: PM
• Reference & Predicate Devices: N/A

Intended Use

The device is intended for medical purposes to provide mobility to children restricted to a sitting position.

Device Description

Not Found

AI/ML Overview

The provided text is a 510(k) clearance letter from the FDA for a mechanical wheelchair, the "Biotech B990K ViVi Wheelchair." This document focuses on the regulatory approval of a hardware medical device based on substantial equivalence to a predicate device, not on AI/algorithm performance. Therefore, the information requested in the prompt regarding acceptance criteria, study details, ground truth, and comparison to AI performance is not contained within this document. The document primarily confirms that the device is substantially equivalent to legally marketed predicate devices and outlines general regulatory compliance requirements.

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).