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)
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.

View all Davismade, Inc. devices

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
Regulatory Context
Review time vs. panel average
39d slower than avg
Panel avg: 115d · 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 18
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