TraX Powered Wheelchair Model 308686-00-0
by Permobil AB
510(k) K993406
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK993406 | Date18 Dec 2000 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
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, 19 Sep 2026
The TraX Powered Wheelchair Model 308686-00-0 is a rear-wheel-driven, motorised mobility device designed for individuals requiring powered assistance. It falls under the classification of a powered wheelchair, providing independent mobility through electric propulsion and proportional control for speed and direction.
This device is operated via a joystick controller (SAFEGATE) and powered by two 12V 97Ah gel batteries, paired with two 12V DC permanent magnet motors featuring integrated parking brakes. The chassis is constructed from welded steel with laser-cut sheet metal details, incorporating a suspension system with stabilisers. It is intended for use in clinical and home settings, with no indication of sterility or single-use requirements. The device holds an FDA 510(k) clearance under classification II and is regulated under regulation number 890.3860.
Other devices from Permobil, Inc.
Questions
AI-generated answers, 19 Sep 2026
What types of environments is the TraX Powered Wheelchair designed for use in?
The TraX Powered Wheelchair (Model 308686-00-0) is explicitly designed for use in both clinical settings, such as hospitals or rehabilitation centers, and home environments. Its robust construction and electric propulsion make it suitable for indoor mobility where powered assistance is required.
How is the TraX Powered Wheelchair powered, and what maintenance considerations should be noted?
The TraX Powered Wheelchair is powered by two 12V 97Ah gel batteries paired with two 12V DC permanent magnet motors. While the device does not specify battery replacement frequency, gel batteries are known for their durability and low maintenance requirements compared to traditional lead-acid batteries. Users should follow manufacturer guidelines for battery care and replacement to ensure optimal performance and safety.
Is the TraX Powered Wheelchair intended for single-use or reusable applications?
The TraX Powered Wheelchair is not described as a single-use device. It is designed for reusable applications in both clinical and home settings, with no indication of sterility requirements. Proper cleaning and maintenance protocols should be followed to ensure longevity and safe use.
What regulatory pathway was followed for the FDA clearance of the TraX Powered Wheelchair?
The TraX Powered Wheelchair received FDA clearance through a 510(k) submission, classified as Substantially Equivalent under Abbreviated clearance type. The device falls under FDA regulation number 890.3860 and was reviewed by the Physical Medicine (PM) Advisory Committee. The clearance was granted on December 18, 2000, following submission on October 8, 1999.
What materials are used in the construction of the TraX Powered Wheelchair chassis, and how does this affect durability?
The TraX Powered Wheelchair features a chassis constructed from welded steel with laser-cut sheet metal details, providing structural integrity and durability. This robust construction is ideal for frequent use in both clinical and home settings, ensuring stability and longevity. The inclusion of a suspension system with stabilizers further enhances its suitability for varied terrains and user needs.