BIOTECH MANUAL WHEELCHAIR A2000 SUPER MOTIVE WHEELCHAIR

• K Number: K020284
• Device Name: BIOTECH MANUAL WHEELCHAIR A2000 SUPER MOTIVE WHEELCHAIR
• Manufacturer: TAIWAN ARMADA ENTERPRISE CO., LTD.
• Date Cleared: 2002-02-08 ( 11 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 person restricted to a sitting position.

Device Description

Not Found

AI/ML Overview

This document is a marketing clearance letter from the FDA for a mechanical wheelchair, the "Biotech A2000 Super Motive Wheelchair." It does not contain information about acceptance criteria or a study proving the device meets specific performance criteria. The letter confirms that the device is substantially equivalent to legally marketed predicate devices and can therefore be marketed.

Therefore, I cannot provide the requested information based on the given input, as the document does not contain:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes or data provenance for a test set.
3. Number or qualifications of experts for ground truth.
4. Adjudication method for a test set.
5. Information about a multi-reader multi-case (MRMC) comparative effectiveness study.
6. Information about a standalone (algorithm-only) performance study.
7. The type of ground truth used.
8. The sample size for a training set.
9. How ground truth for a training set was established.

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).