Cleared Traditional

K152056 - Winco Model S550 Stretchair (FDA 510(k) Clearance)

Class II Physical Medicine device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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.

Device Classification

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.