Compact Wheelchair Platform
by Design Specific Fletcher 510(k)
Active
510(k) K101723
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK101723 | Date23 Dec 2010 | 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- Withdrawn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
- INO
- Device Class
- Class II
- Regulation
- 21 CFR Part 890.3110
- Advisory Committee
- Physical Medicine
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The Compact Wheelchair Platform is an electric, positioning chair designed to provide tiltable, wheelchair-accessible support for clinical procedures. It is classified as a positioning device and is intended to reduce patient transfer hazards by enabling procedures to be performed directly on the wheelchair-bound user.
This device is used in clinical settings such as dental or medical procedures, where patients remain seated in their wheelchairs. Powered by 24V batteries or mains, it tilts up to 60 degrees via hydraulic cylinders. The platform is supplied as a reusable medical device and has received FDA 510(k) clearance under the Traditional pathway, classified as a Class II device under regulation number 890.3110. No third-party review was involved in its authorization.
Questions
AI-generated answers, 19 Sep 2026
Is the Compact Wheelchair Platform designed for single-use or can it be reused in clinical settings?
The Compact Wheelchair Platform is explicitly supplied as a reusable medical device. Since it is intended for clinical procedures like dental or medical treatments, it must be properly cleaned, disinfected, and maintained between uses to ensure patient safety and device integrity.
What power sources are available for operating the Compact Wheelchair Platform, and how does it achieve its tilt function?
The device can be powered by either 24V batteries or mains electricity. It achieves its tilt function through hydraulic cylinders, allowing the platform to tilt up to 60 degrees for positioning during procedures.
What tilt range does the Compact Wheelchair Platform provide, and how might this benefit patients during procedures?
The platform tilts up to 60 degrees, which helps reduce patient transfer hazards by enabling clinical procedures—such as dental or medical treatments—to be performed while the patient remains seated in their wheelchair. This minimizes movement and discomfort.
How is the Compact Wheelchair Platform classified under FDA regulations, and what does this mean for its use in clinical settings?
The device is classified as a Class II medical device under FDA regulation number 890.3110, with clearance granted through the Traditional 510(k) pathway. This classification means it undergoes stricter manufacturing controls and post-market surveillance to ensure safety and effectiveness in clinical settings like dental or medical procedures.
What types of clinical procedures is the Compact Wheelchair Platform intended to support, and why is it particularly useful for wheelchair-bound patients?
The platform is designed for clinical procedures where patients remain seated in their wheelchairs, such as dental treatments or medical examinations. Its tiltable design reduces the need for transfers, lowering the risk of falls or injuries for wheelchair-bound patients during procedures.