PRIME ZOOM STRETCHER— 510(k) K140095

Substantially Equivalent

Stryker Corporation

FDA 510(k) clearance K140095 for PRIME ZOOM STRETCHER, Substantially Equivalent on 2014-05-20. Applicant: Stryker Corporation.

Clearance details

Applicant: Stryker Corporation
Product code: Code INK
Advisory panel: Physical Medicine
Date received: 2014-01-14
Decision date: 2014-05-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Portage, MI, US

Download summary PDF View on FDA.gov ↗

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.