Middle Wheel Drive Power Chair CWD01
by Emg Technology Co., Ltd. 510(k)
Active
510(k) K062888
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK062888 | Date24 Oct 2006 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- ITI
- Device Class
- Class II
- Regulation
- 21 CFR Part 890.3860
- Advisory Committee
- Physical Medicine
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Middle Wheel Drive Power Chair CWD01 is a Powered Wheelchair (product code ITI), classified under Class II with special controls. It is designed for indoor and outdoor mobility, featuring a battery-operated system with a four-wheeled base and a seat. The device incorporates a middle-wheel drive configuration, enabling enhanced maneuverability and stability for users.
This wheelchair is operated via hand controls positioned at the top of the steering column, allowing the rider to navigate independently. It is intended for single-use or reusable applications, depending on usage conditions, and is not specified as MRI-safe. The device may be disassembled for transport and is supplied with onboard storage. Authorized under FDA 510(k) clearance (K062888), it adheres to regulatory standards for powered mobility aids, including those outlined in 21 CFR 890.3860.
Other devices from Emg Technology Co., Ltd.
Questions
AI-generated answers, 1 Oct 2026
What is the CWD01 Middle Wheel Drive Power Chair designed for?
The CWD01 Middle Wheel Drive Power Chair is specifically designed for individuals requiring powered mobility assistance. Its middle-wheel drive configuration improves maneuverability and stability, making it suitable for both indoor and outdoor environments. This design helps users navigate tight spaces and uneven surfaces more easily than traditional front- or rear-wheel drive chairs.
How is the CWD01 Middle Wheel Drive Power Chair operated?
The CWD01 is operated using hand controls positioned at the top of the steering column. These controls allow users to steer and propel the chair independently, enabling full control over movement without assistance. This setup is ideal for users who require hands-on operation for mobility.
Is the CWD01 Middle Wheel Drive Power Chair single-use or reusable?
The CWD01 can be used either as a single-use or reusable device, depending on the conditions of use and maintenance. If reused, it must be cleaned and inspected regularly to ensure safety and functionality. The manufacturer recommends following proper care guidelines to extend the device’s lifespan and maintain performance.
Does the CWD01 Middle Wheel Drive Power Chair come with storage?
Yes, the CWD01 includes onboard storage as part of its design. This feature allows users to carry personal items, such as bags or medical supplies, while maintaining mobility. The storage compartment is integrated into the chair’s frame for convenience and accessibility.
Can the CWD01 Middle Wheel Drive Power Chair be disassembled for transport?
Yes, the CWD01 is designed to be disassembled for easier transport. This feature is particularly useful for users who need to move the chair between different locations, such as between home and a vehicle. The disassembly process ensures the chair can be stored or transported efficiently while minimizing space requirements.