(134 days)
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.
§ 890.3860 Powered wheelchair.
(a)
Identification. A powered wheelchair is a battery-operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.(b)
Classification. Class II (performance standards).