Cleared Traditional

K090256 - POWER STANDING DANI

K090256 is an FDA 510(k) clearance for POWER STANDING DANI, manufactured by Davismade, Inc.. The device is a Class 2 Physical Medicine device with product code IPL cleared through the Traditional 510(k) pathway after a 154-day FDA review.

K090256 · Davismade, Inc. · Physical Medicine device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2009
Decision
154d
Days
Class 2
Risk

K090256 is an FDA 510(k) clearance for the POWER STANDING DANI. Classified as Wheelchair, Standup (product code IPL), Class II - Special Controls.

Submitted by Davismade, Inc. (Flint, US). The FDA issued a Cleared decision on July 6, 2009 after a review of 154 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 - K090256

510(k) Number K090256 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 02, 2009
Decision Date July 06, 2009
Days to Decision 154 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
38d slower than avg
Panel avg: 116d · This submission: 154d
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 64
Devices cleared under the same product code (IPL) and FDA review panel - the closest regulatory comparables to K090256.
E-TENG MODEL EOR 1
K122562 · E-Teng Technology, Inc. · Aug 2013
HIROLLER ELEVATING WHEELCHAIR
K102837 · Max Mobility, LLC · Dec 2010
COMFORT STANDING WHEELCHAIR, HERO SERIES
K102734 · Comfort Orthopedic Co., Ltd. · Dec 2010
LEVO C3
K083017 · Levo AG · Oct 2008
BALDER FINESSE AND JUNIOR POWERED WHEELCHAIRS (WITH STAND-UP OPTION)
K072475 · Etac Sverige AB · Dec 2007
LLOYD LINDEN, MODEL E04
K071761 · Lloyd Linden, Inc. · Aug 2007
K090256 · POWER STANDING DANI
Download PDF FDA Summary Davismade, Inc.