720 Power Base
by Fortress Scientific, Ltd. 510(k)
Active
510(k) K933864
Overview
The 720 Power Base is a Powered Wheelchair Base, designed as a mobility assist device for individuals requiring electric propulsion. It serves as the foundational platform for powered wheelchair systems, providing the mechanical and electrical components necessary to drive the wheelchair’s movement, including motors, controls, and battery integration. This device is classified under Wheelchair, Powered and is intended for use in physical medicine applications, supporting independent mobility for users with limited ambulatory capacity.
The 720 Power Base is supplied as a reusable component, intended for integration into powered wheelchair assemblies. It is regulated under FDA 510(k) clearance (K933864) and falls under Device Class II (regulation 890.3860), with a Substantially Equivalent (SESE) determination by the Physical Medicine (PM) Advisory Committee. No specific sterility or single-use requirements are indicated; instead, it is designed for durable use within wheelchair systems. The device is not explicitly noted for MRI compatibility or size variations in the provided data.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK933864 | Date28 Mar 1994 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- 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
- FDA applicant
- Fortress Scientific , Ltd.
- Device Class
- Class II
- Regulation
- 21 CFR Part 890.3860
- Advisory Committee
- Physical Medicine
- FDA Decision
- SESE Substantially Equivalent
Other devices from Fortress Scientific, Ltd.
Questions
What is the 720 Power Base used for?
The 720 Power Base is designed as the foundational component of powered wheelchair systems. It provides the mechanical and electrical components—such as motors, controls, and battery integration—that enable electric propulsion. This device is specifically intended for individuals requiring mobility assistance due to limited ambulatory capacity, supporting independent movement in physical medicine applications.
Is the 720 Power Base single-use or reusable?
The 720 Power Base is explicitly designed for durable, reusable use within wheelchair assemblies. Unlike single-use medical devices, it is built to integrate into powered wheelchair systems over extended periods, requiring maintenance rather than disposal after each use.
Does the 720 Power Base require sterilization?
No specific sterility requirements are indicated for the 720 Power Base. As a reusable component for wheelchair systems, it is not intended for sterile procedures or environments. Cleaning and maintenance protocols would focus on hygiene rather than sterilization.
What regulatory pathway does the 720 Power Base follow?
The 720 Power Base is regulated under the FDA’s 510(k) clearance process, with a clearance number of K933864. It falls under Device Class II (regulation 890.3860) and received a Substantially Equivalent (SESE) determination by the Physical Medicine (PM) Advisory Committee. This classification confirms its compliance with U.S. medical device regulations for powered wheelchairs.
Are there variations in size or model for the 720 Power Base?
The provided data does not specify size variations or multiple model references for the 720 Power Base. It is presented as a singular, standardized platform for wheelchair propulsion, though compatibility with different wheelchair frames or accessories may depend on manufacturer-specific configurations.