Cleared Traditional

K895596 - FORTRESS 1000FS ADD-ON POWER UNIT

K895596 is an FDA 510(k) clearance for FORTRESS 1000FS ADD-ON POWER UNIT, 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 38-day FDA review.

K895596 · Fortress Scientific , Ltd. · Physical Medicine device
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Oct 1989
Decision
38d
Days
Class 2
Risk

K895596 is an FDA 510(k) clearance for the FORTRESS 1000FS ADD-ON POWER UNIT. 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 October 23, 1989 after a review of 38 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Fortress Scientific , Ltd. devices

FDA 510(k) Submission Details - K895596

510(k) Number K895596 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 15, 1989
Decision Date October 23, 1989
Days to Decision 38 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
77d faster than avg
Panel avg: 115d · This submission: 38d
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 K895596.
FORTRESS 760FS POWER WHEELCHAIR
K900038 · Fortress Scientific , Ltd. · Jan 1990
FORTRESS VICTORY POWER WHEELCHAIR
K900039 · Fortress Scientific , Ltd. · Jan 1990
FORTRESS SPIRIT POWER WHEELCHAIR
K900040 · Fortress Scientific , Ltd. · Jan 1990
FORTRESS 655FS POWER WHEELCHAIR
K895595 · Fortress Scientific , Ltd. · Oct 1989
ARROW MICRO COMPUTER CONTROL
K885212 · Invacare Corp. · Mar 1989
ARROW MICRO COMPUTER CONTROL SWITCH & ENVIRON. SYS
K885261 · Invacare Corp. · Mar 1989