Cleared Traditional

K011530 - VERTRAN STANDING WHEELCHAIR

K011530 is an FDA 510(k) clearance for VERTRAN STANDING WHEELCHAIR, manufactured by Fena Design, Inc.. The device is a Class 2 Physical Medicine device with product code IPL cleared through the Traditional 510(k) pathway after a 152-day FDA review.

K011530 · Fena Design, Inc. · Physical Medicine device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2001
Decision
152d
Days
Class 2
Risk

K011530 is an FDA 510(k) clearance for the VERTRAN STANDING WHEELCHAIR. Classified as Wheelchair, Standup (product code IPL), Class II - Special Controls.

Submitted by Fena Design, Inc. (Stillwater, US). The FDA issued a Cleared decision on October 16, 2001 after a review of 152 days - an extended review cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.3900 - 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 - K011530

510(k) Number K011530 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 17, 2001
Decision Date October 16, 2001
Days to Decision 152 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
36d slower than avg
Panel avg: 116d · This submission: 152d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IPL Device Classification - Class 2, Special Controls

Product Code IPL Wheelchair, Standup
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.3900
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 - IPL Wheelchair, Standup

All 65
Devices cleared under the same product code (IPL) and FDA review panel - the closest regulatory comparables to K011530.
RABBIT MOBILE STANDING FRAME
K030882 · R82 A/S · Apr 2003
LEVO COMBI
K030893 · Levo AG · Apr 2003
NEW HEIGHTS ELECTRIC ELEVATING POWER WHEELCHAIR MODEL NO. 08 02 SERIES
K021165 · Bromac Assistive Technology · Jul 2002
NEW HEIGHTS ELECTRIC ELEVATING MANUAL WHEELCHAIR
K012345 · Bromac Assistive Technology · Oct 2001
STANNAH POWER CHAIR, MODEL 201
K994083 · Stannah Power Chairs , Ltd. · Apr 2001
THE LIBERATOR
K984391 · Liberator Wheelchairs, Inc. · Sep 1999
K011530 · VERTRAN STANDING WHEELCHAIR
Download PDF FDA Summary Fena Design, Inc.