730 Power Base
by Fortress Scientific, Ltd. 510(k)
Active
510(k) K933858
Overview
The 730 Power Base is a powered wheelchair base designed for mobility assistance. It is classified as a Wheelchair, Powered under FDA nomenclature, intended to provide independent movement for users with limited mobility. The device incorporates motorized propulsion systems to facilitate propulsion and maneuvering, typically used in clinical and home settings for individuals requiring electric mobility support.
This device is supplied as a reusable component for wheelchair systems and is regulated under FDA 510(k) clearance (K933858) with a classification of Class II (ITI product code). It is intended for integration into powered wheelchair assemblies and does not require single-use or sterile conditions. No MRI safety or specific storage instructions are noted in the regulatory data. The device was cleared under Substantially Equivalent for Some Indications in Physical Medicine, with the original submission received in 1993 and cleared in 1994.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SN | NumberK933858 | 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- Withdrawn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
- SN
Other devices from Fortress Scientific, Ltd.
Questions
What is the 730 Power Base used for?
The 730 Power Base is a motorized component designed specifically for powered wheelchair systems. It provides propulsion and maneuvering assistance to individuals with limited mobility, enabling independent movement in both clinical and home environments. This device is intended to be integrated into larger wheelchair assemblies to enhance mobility support.
Is the 730 Power Base single-use or reusable?
The 730 Power Base is supplied as a reusable component. It is not intended for single-use applications, meaning it can be used repeatedly across multiple wheelchair systems as long as it remains functional and meets safety standards. Reusability is a key feature for cost-effective mobility solutions in both healthcare and home settings.
Does the 730 Power Base require sterile conditions?
No, the 730 Power Base does not require sterile conditions for use. Since it is designed as a reusable component for wheelchair systems and not for invasive or sterile procedures, standard cleaning and maintenance protocols apply. Always follow manufacturer guidelines for proper care to ensure longevity and safety.
Are there specific storage instructions for the 730 Power Base?
The regulatory data for the 730 Power Base does not specify any particular storage instructions. However, it is generally recommended to store the device in a clean, dry environment away from direct sunlight, extreme temperatures, and moisture to prevent damage. Ensure it is protected from physical impacts and stored in a manner that maintains its structural integrity.
What regulatory pathway was followed for the 730 Power Base?
The 730 Power Base was cleared through the FDA’s 510(k) pathway under the classification of Class II (ITI product code). It was determined to be substantially equivalent for some indications in physical medicine, with the original submission received in 1993 and cleared in 1994. This pathway is used for devices that are not significantly different from legally marketed devices.