Cleared Traditional

K152056 - Winco Model S550 Stretchair

K152056 is an FDA 510(k) clearance for Winco Model S550 Stretchair, manufactured by Winco Manufacturing, LLC. The device is a Class 2 Physical Medicine device with product code INK cleared through the Traditional 510(k) pathway after a 262-day FDA review.

K152056 · Winco Manufacturing, LLC · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2016
Decision
262d
Days
Class 2
Risk

K152056 is an FDA 510(k) clearance for the Winco Model S550 Stretchair. Classified as Stretcher, Wheeled, Powered (product code INK), Class II - Special Controls.

Submitted by Winco Manufacturing, LLC (Ocala, US). The FDA issued a Cleared decision on April 11, 2016 after a review of 262 days - an extended review cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.3690 - 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 Winco Manufacturing, LLC devices

FDA 510(k) Submission Details - K152056

510(k) Number K152056 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 24, 2015
Decision Date April 11, 2016
Days to Decision 262 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
147d slower than avg
Panel avg: 115d · This submission: 262d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

INK Device Classification - Class 2, Special Controls

Product Code INK Stretcher, Wheeled, Powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.3690
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.