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The intended use of the Model PW is to provide mobility to adults with the ability to place themselves in a sitting position on the Wheelchair and have the capacity to operate a simple hand control.

Model PW, Electric Power Wheelchair

This document is a 510(k) clearance letter from the FDA for a powered wheelchair, Model PW. It does not contain information about acceptance criteria or a study proving that the device meets specific performance criteria.

The information provided in the document is limited to:

• Device Name: Model PW, Electric Power Wheelchair
• Regulation Number: 21 CFR 890.3860
• Regulation Name: Powered wheelchair
• Regulatory Class: II
• Product Code: ITI
• 510(k) Number: K024175
• Manufacturer: SUNPLEX TECHNOLOGY Co. Ltd.
• Intended Use: To provide mobility to adults with the ability to place themselves in a sitting position on the Wheelchair and have the capacity to operate a simple hand control.
• Classification: Over-The-Counter Use

The letter indicates that the device has been determined to be "substantially equivalent" to legally marketed predicate devices, which means it is considered as safe and effective as a device already on the market. However, it does not describe specific performance tests or acceptance criteria for the Model PW itself, nor does it detail a study conducted to demonstrate such criteria. The substantial equivalence determination is based on a comparison to predicate devices, not on explicit performance metrics presented in this document.

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