Cleared Traditional

K120302 - MECHANICAL WHEELCHAIR

K120302 is an FDA 510(k) clearance for MECHANICAL WHEELCHAIR, manufactured by Novaf Andalucia 2007, SL. The device is a Class 2 Physical Medicine device with product code IQC cleared through the Traditional 510(k) pathway after a 156-day FDA review.

K120302 · Novaf Andalucia 2007, SL · Physical Medicine device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2012
Decision
156d
Days
Class 2
Risk

K120302 is an FDA 510(k) clearance for the MECHANICAL WHEELCHAIR. Classified as Wheelchair, Special Grade (product code IQC), Class II - Special Controls.

Submitted by Novaf Andalucia 2007, SL (Rota, ES). The FDA issued a Cleared decision on July 6, 2012 after a review of 156 days - an extended review cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.3880 - 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.

FDA 510(k) Submission Details - K120302

510(k) Number K120302 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 01, 2012
Decision Date July 06, 2012
Days to Decision 156 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
40d slower than avg
Panel avg: 116d · This submission: 156d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IQC Device Classification - Class 2, Special Controls

Product Code IQC Wheelchair, Special Grade
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.3880
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 - IQC Wheelchair, Special Grade

All 20
Devices cleared under the same product code (IQC) and FDA review panel - the closest regulatory comparables to K120302.
Hippocampe Marathon and Trail
K251570 · Vipamat Sarl · Jun 2025
RENEGADE WHEELCHAIR
K082857 · Alpha One · Jan 2009
HIPPOCAMPE WHEELCHAIR
K051709 · Vipamat Technologie · Aug 2005
CALIFORNIA COMFORT FOUR WHEEL
K895384 · Jubilee Scooters, Inc. · Sep 1989
PCI CUSTOM DESIGN SERIES
K861943 · Poston & Cole Intl. · May 1986
POIRIER VARIABLE WHEELCHAIR
K840234 · Poirier S.A. · Feb 1984
K120302 · MECHANICAL WHEELCHAIR
Download PDF FDA Summary Novaf Andalucia 2007,…