Cleared Traditional

K932329 - HOVEROUND POWER CHAIR

K932329 is the FDA 510(k) clearance for HOVEROUND POWER CHAIR by Hoveround Corp.. It is a Class 2 Physical Medicine device (product code ITI) cleared through the Traditional 510(k) pathway after a 319-day FDA review.

K932329 · Hoveround Corp. · Physical Medicine device
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Mar 1994
Decision
319d
Days
Class 2
Risk

K932329 is an FDA 510(k) clearance for the HOVEROUND POWER CHAIR. Classified as Wheelchair, Powered (product code ITI), Class II - Special Controls.

Submitted by Hoveround Corp. (Sarasota, US). The FDA issued a Cleared decision on March 28, 1994 after a review of 319 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 Hoveround Corp. devices

Submission Details

510(k) Number K932329 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received May 13, 1993
Decision Date March 28, 1994
Days to Decision 319 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
204d slower than avg
Panel avg: 115d · This submission: 319d
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 K932329.
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MICRO COMPUTER CONTROLS, MODEL# MCC-MK-RII-X
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