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Fortress C-500 Microprocessor Controller

by Fortress Scientific, Ltd. 510(k)

Active United States

510(k) K930088

Overview

The Fortress C-500 Microprocessor Controller is a powered wheelchair device classified under device class 2 and product code ITI. It is substantially equivalent to a legally marketed device and received traditional 510(k) clearance from the FDA.

The device is authorized under regulation number 890.3860 and is associated with the Physical Medicine advisory committee. It was cleared by the FDA on March 28, 1994, under k-number K930088, and is manufactured by Fortress Scientific, Ltd.

AI-generated from registry data, 19 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK930088 Date28 Mar 1994ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
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  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

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

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Questions

  • What is the primary use of the Fortress C-500 Microprocessor Controller in clinical settings?

    The Fortress C-500 Microprocessor Controller is designed as a powered wheelchair control system, specifically classified under product code ITI (Intelligent/Instrumentation). It is intended for use with powered wheelchairs to enhance mobility for individuals with limited mobility, though its exact clinical indications are not specified beyond its role as a control mechanism for powered mobility devices.

  • How was the Fortress C-500 Microprocessor Controller cleared by the FDA, and what does that mean for its regulatory status?

    The device received traditional 510(k) clearance from the FDA on March 28, 1994, under k-number K930088. This means it was determined to be substantially equivalent to a legally marketed device already on the market, fulfilling FDA requirements for Class II medical devices without requiring a full premarket approval process. The clearance was reviewed by the Physical Medicine advisory committee under regulation number 890.3860.

  • Is the Fortress C-500 Microprocessor Controller intended for single-use or reusable applications?

    The provided data does not explicitly state whether the Fortress C-500 Microprocessor Controller is designed for single-use or reuse. However, as a powered wheelchair control system, such devices are typically durable and reusable for long-term use with proper maintenance. For precise usage guidelines, refer to the manufacturer’s instructions or technical specifications.

  • What regulatory route was followed for the Fortress C-500 Microprocessor Controller’s approval, and which advisory committee was involved?

    The Fortress C-500 Microprocessor Controller followed the traditional 510(k) pathway, a premarket notification process for Class II devices. Its submission was reviewed by the Physical Medicine (PM) advisory committee, which provides expert input on powered mobility devices. The device was cleared under FDA regulation number 890.3860 and associated with powered wheelchairs.