Winco Model S550 Stretchair— 510(k) K152056

Name: FDA 510(k) clearance K152056
Creator: U.S. Food and Drug Administration
Published: 2016-04-11

Substantially Equivalent

Winco Manufacturing, LLC

FDA 510(k) clearance K152056 for Winco Model S550 Stretchair, Substantially Equivalent on 2016-04-11. Applicant: Winco Manufacturing, LLC. Device class: 2.

Clearance details

Applicant: Winco Manufacturing, LLC
Product code: Code INK
Device class: Class 2
Regulation: 21 CFR 890.3690
Advisory panel: Physical Medicine
Date received: 2015-07-24
Decision date: 2016-04-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ocala, FL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code INK

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K140095 — PRIME ZOOM STRETCHER2014-05-20
K112502 — PROCEDURAL STRECHER WITH INTELLIDRIVE P80002011-09-19
K110671 — WINCO STRETCHAIR2011-04-22
K102236 — HOVERTRANS TRANSFORMER WITH POWER DRIVE MODEL HTT-650P2010-11-18
K091043 — POWER DRIVE CHAIR, MODEL: TMM62009-05-11

Adverse events under product code INK

product code INK

Malfunction: 708
Other: 1
Total: 709

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.