A08 Power Wheelchair
by Kunshan Aoshida Electric Technology Co., Ltd China EUDAMED510(k)
510(k) K163204
Product code ITI
Overview
The A08 Power Wheelchair is a motorised mobility device designed for individuals with limited mobility, enabling independent movement and enhanced accessibility. Classified as a Powered Wheelchair, it is intended to assist users in navigating indoor and outdoor environments with greater ease, supporting physical medicine applications through customisable features for user-specific needs.
This device is supplied as a reusable medical product, intended for long-term use under professional supervision. It is regulated under FDA 510(k) clearance and the EU Medical Device Regulation (MDR), with a classification as a Class II device. The wheelchair is not single-use and requires periodic maintenance, including battery checks and mechanical inspections, to ensure safe operation. No specific MRI safety information is provided, and storage conditions should follow manufacturer guidelines to preserve functionality and hygiene.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE 510(k) | NumberK163204 | Date5 May 2017 | StatusActive |
| European Union | CE/MDR EUDAMED | Number— | Date— | StatusActive |
Coverage
- Active
- Not covered
- European Union
- United States
Specification
- 510(k) Number
- FDA Product Code
- ITI
- FDA applicant
- Kunshan Aoshida Electric Technology Co., Ltd.
- Device Class
- Class II
- Regulation
- 21 CFR Part 890.3860
- Advisory Committee
- Physical Medicine
- FDA Decision
- SESE Substantially Equivalent
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Questions
What types of environments is the A08 Power Wheelchair designed to help users navigate, and how does it support customization for individual needs?
The A08 Power Wheelchair is specifically designed for indoor and outdoor use, enabling users with limited mobility to move independently and access various environments with greater ease. It supports customization through adjustable features tailored to user-specific needs, though the exact configurations are not detailed in the provided data. This adaptability aligns with its classification under Physical Medicine, suggesting it is intended for clinical or therapeutic use where personalized adjustments are beneficial.
Is the A08 Power Wheelchair intended for single-use or long-term reuse, and what maintenance is required to ensure safe operation?
The A08 Power Wheelchair is explicitly described as a reusable medical product intended for long-term use under professional supervision. To maintain safe operation, it requires periodic maintenance, including battery checks and mechanical inspections, as outlined in the device description. These measures ensure reliability and functionality over extended use.
What regulatory pathways has the A08 Power Wheelchair followed, and which medical specialty does it primarily support?
The A08 Power Wheelchair has undergone FDA 510(k) clearance and complies with the EU Medical Device Regulation (MDR), classified as a Class II device. Its primary medical specialty is Physical Medicine, as indicated by the advisory committee and medical specialty descriptions in the data. This classification reflects its role in assisting mobility for patients requiring specialized medical support.
Are there any specific storage guidelines mentioned for the A08 Power Wheelchair to preserve its functionality and hygiene?
While the data does not provide detailed storage instructions, it explicitly states that storage conditions should follow manufacturer guidelines to maintain functionality and hygiene. This ensures the wheelchair remains safe and operational for long-term use, particularly in clinical or home settings where cleanliness and reliability are critical.
Properties & raw data
Show properties, registry sources and raw records
Sources (2)
- FDA 510(k) K163204
- EUDAMED