Cleared Abbreviated

K130644 - PEDIATRIC FOLDING WHEELCHAIR (FDA 510(k) Clearance)

Class I Physical Medicine device.

K130644 · Columbia Medical Mfg, LLC · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2013
Decision
219d
Days
Class 1
Risk

K130644 is an FDA 510(k) clearance for the PEDIATRIC FOLDING WHEELCHAIR. Classified as Stroller, Adaptive (product code LBE), Class I - General Controls.

Submitted by Columbia Medical Mfg, LLC (Santa Fe Springs, US). The FDA issued a Cleared decision on October 16, 2013 after a review of 219 days - an extended review cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.3850 - the FDA physical medicine device framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Columbia Medical Mfg, LLC devices

Submission Details

510(k) Number K130644 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 11, 2013
Decision Date October 16, 2013
Days to Decision 219 days
Submission Type Abbreviated
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
104d slower than avg
Panel avg: 115d · This submission: 219d
Pathway characteristics
Standards-based clearance path.

Device Classification

Product Code LBE Stroller, Adaptive
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.3850
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.