WINCO STRETCHAIR— 510(k) K110671

Name: FDA 510(k) clearance K110671
Creator: U.S. Food and Drug Administration
Published: 2011-04-22

Substantially Equivalent

Winco Mfg., LLC

FDA 510(k) clearance K110671 for WINCO STRETCHAIR, Substantially Equivalent on 2011-04-22. Applicant: Winco Mfg., LLC. Device class: 2.

Clearance details

Applicant: Winco Mfg., LLC
Product code: Code INK
Device class: Class 2
Regulation: 21 CFR 890.3690
Advisory panel: Physical Medicine
Date received: 2011-03-09
Decision date: 2011-04-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ocala, FL, US

Download summary PDF View on FDA.gov ↗

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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.