Cleared Traditional

K913645 - SPECIALTY CONTROLS INTERFACE

K913645 is the FDA 510(k) clearance for SPECIALTY CONTROLS INTERFACE by Everest & Jennings, Inc.. It is a Class 2 Physical Medicine device (product code ITI) cleared through the Traditional 510(k) pathway after a 123-day FDA review.

K913645 · Everest & Jennings, Inc. · Physical Medicine device
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Dec 1991
Decision
123d
Days
Class 2
Risk

K913645 is an FDA 510(k) clearance for the SPECIALTY CONTROLS INTERFACE. Classified as Wheelchair, Powered (product code ITI), Class II - Special Controls.

Submitted by Everest & Jennings, Inc. (Camarillo, US). The FDA issued a Cleared decision on December 17, 1991 after a review of 123 days - within the typical 510(k) review window.

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. Standard predicate reliance. 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 Everest & Jennings, Inc. devices

Submission Details

510(k) Number K913645 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 16, 1991
Decision Date December 17, 1991
Days to Decision 123 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
8d slower than avg
Panel avg: 115d · This submission: 123d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 171
Devices cleared under the same product code (ITI) and FDA review panel - the closest regulatory comparables to K913645.
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