Winco Model S550 Stretchair— 510(k) K152056

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.

Clearance details

Applicant
Winco Manufacturing, LLC
Product code
Code INK
Advisory panel
Physical Medicine
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Ocala, FL, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code INK

product code INK
Malfunction
708
Other
1
Total
709

Source: openFDA MAUDE database, through . 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.