Trail Chair
by Winchester Industries, Inc.
510(k) K834498
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK834498 | Date30 Jan 1984 | StatusActive |
Recalls
No FDA recalls found in the data synced 5 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- IQC
- Device Class
- Class II
- Regulation
- 21 CFR Part 890.3880
- Advisory Committee
- Physical Medicine
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Trail Chair is a Wheelchair, Special Grade, designed for mobility assistance in physical medicine settings. It is classified as a Class II medical device under FDA regulations, intended for patients requiring transport or positioning support. The device is engineered to provide stability and ease of use for individuals with limited mobility, particularly in outdoor or transitional environments.
Supplied as a reusable device, the Trail Chair is intended for use in clinical, rehabilitation, or physical therapy settings. It is not classified as single-use and requires proper maintenance to ensure durability and safety. The device is regulated under FDA 510(k) clearance (K834498) and falls under product code IQC, adhering to standards for wheelchairs in physical medicine applications. No specific sterility or MRI safety information is provided in the regulatory data.
Questions
AI-generated answers, 1 Oct 2026
What is the Trail Chair designed for?
The Trail Chair is a Wheelchair, Special Grade intended for mobility assistance in physical medicine settings. It provides stability and ease of use for patients requiring transport or positioning support, particularly in outdoor or transitional environments. Its design prioritizes durability and adaptability for clinical, rehabilitation, or physical therapy use.
Is the Trail Chair single-use or reusable?
The Trail Chair is not single-use—it is supplied as a reusable device. Proper maintenance is required to ensure its longevity, safety, and continued functionality over multiple uses. This aligns with its classification as a Class II medical device under FDA regulations.
What regulatory pathway does the Trail Chair follow?
The Trail Chair is regulated under the FDA 510(k) clearance process, specifically with clearance number K834498. It falls under product code IQC and is classified as Substantially Equivalent to predicate devices. The device was reviewed by the Physical Medicine (PM) Advisory Committee and is intended for use in physical medicine applications.
Does the Trail Chair require special storage or handling?
While specific storage instructions aren’t detailed in regulatory data, the Trail Chair’s reusable design implies it should be stored in a clean, dry environment to prevent wear or contamination. Regular maintenance (e.g., lubrication, inspection) is recommended to ensure safety and functionality, especially in clinical or outdoor settings where it may be frequently used.
Is sterility or MRI safety information provided for the Trail Chair?
No, the available regulatory data does not include details about sterility requirements or MRI safety for the Trail Chair. Users should confirm compatibility with their facility’s protocols if MRI exposure is a concern. The device is not classified as single-use, so sterility is not a primary consideration.