Cleared Traditional

K932597 - FORTRESS C-300 MICROPROCESSOR CONTROLLER

K932597 is an FDA 510(k) clearance for FORTRESS C-300 MICROPROCESSOR CONTROLLER, manufactured by Fortress Scientific , Ltd.. The device is a Class 2 Physical Medicine device with product code ITI cleared through the Traditional 510(k) pathway after a 304-day FDA review.

K932597 · Fortress Scientific , Ltd. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1994
Decision
304d
Days
Class 2
Risk

K932597 is an FDA 510(k) clearance for the FORTRESS C-300 MICROPROCESSOR CONTROLLER. Classified as Wheelchair, Powered (product code ITI), Class II - Special Controls.

Submitted by Fortress Scientific , Ltd. (Washington, US). The FDA issued a Cleared decision on March 28, 1994 after a review of 304 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.3860 - the FDA physical medicine device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Physical Medicine review framework, consistent with the majority of Class II 510(k) submissions.

View all Fortress Scientific , Ltd. devices

FDA 510(k) Submission Details - K932597

510(k) Number K932597 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received May 28, 1993
Decision Date March 28, 1994
Days to Decision 304 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
189d slower than avg
Panel avg: 115d · This submission: 304d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ITI Device Classification - Class 2, Special Controls

Product Code ITI Wheelchair, Powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.3860
Definition A Powered Wheelchair Is A Battery-operated Device With Wheels That Is Intended For Medical Purposes To Provide Mobility To Persons Restricted To A Sitting Position. Fda Interprets “mobility To Persons Restricted To A Sitting Position” To Mean The Device Type Is Intended To Provide Mobility To Individuals Who Have Mobility Impairments And Require An Assistive Device For Mobility. Note: This Type Of Device Is Not Intended To Climb Stairs (see Product Code: Imk).
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Physical Medicine devices follow this clearance model.

Regulatory Peers - ITI Wheelchair, Powered

All 208
Devices cleared under the same product code (ITI) and FDA review panel - the closest regulatory comparables to K932597.
MODEL MCC - MKIV MICRO COMPUTER CONTROLS
K940972 · Invacare Corp. · Jun 1994
KID POWER
K925865 · Everest & Jennings, Inc. · Mar 1994
FORTRESS C-500 MICROPROCESSOR CONTROLLER
K930088 · Fortress Scientific , Ltd. · Mar 1994
A901 TILT IN SPACE
K933853 · Fortress Scientific , Ltd. · Mar 1994
770 POWER BASE
K933854 · Fortress Scientific , Ltd. · Mar 1994
S490 SEATING SYSTEM
K933855 · Fortress Scientific , Ltd. · Mar 1994