Cleared Traditional

K855086 - KATALAVOX VOICE-ACTIVATED SWITCHING DEVICE

K855086 is an FDA 510(k) clearance for KATALAVOX VOICE-ACTIVATED SWITCHING DEVICE, manufactured by Kempf Co.. The device is a Class 2 Physical Medicine device with product code ITI cleared through the Traditional 510(k) pathway after a 105-day FDA review.

K855086 · Kempf Co. · Physical Medicine device
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Apr 1986
Decision
105d
Days
Class 2
Risk

K855086 is an FDA 510(k) clearance for the KATALAVOX VOICE-ACTIVATED SWITCHING DEVICE. Classified as Wheelchair, Powered (product code ITI), Class II - Special Controls.

Submitted by Kempf Co. (Sunnyvale, US). The FDA issued a Cleared decision on April 4, 1986 after a review of 105 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 Kempf Co. devices

FDA 510(k) Submission Details - K855086

510(k) Number K855086 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 20, 1985
Decision Date April 04, 1986
Days to Decision 105 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
10d faster than avg
Panel avg: 115d · This submission: 105d
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 406
Devices cleared under the same product code (ITI) and FDA review panel - the closest regulatory comparables to K855086.
CHILD'S ROLLS POWERED WHEELCHAIR
K863250 · Invacare Corp. · Aug 1986
RUNAROUND
K862405 · Everest & Jennings, Inc. · Jul 1986
SPRINT (POWER DRIVE WHEELCHAIR)
K861729 · Everest & Jennings, Inc. · May 1986
CRUISER
K854164 · Invacare Corp. · Jan 1986
MODULAR POWER BASE
K854051 · Everest & Jennings, Inc. · Dec 1985
MARATHON POWER DRIVE-WHEELCHAIR
K854153 · Everest & Jennings, Inc. · Dec 1985