Freedom Spinal Cord Stimulator System— 510(k) K160600

Substantially Equivalent

Stimwave Technologies Incorporated

FDA 510(k) clearance K160600 for Freedom Spinal Cord Stimulator System, Substantially Equivalent on 2016-08-26. Applicant: Stimwave Technologies Incorporated.

Clearance details

Applicant: Stimwave Technologies Incorporated
Product code: Code GZB
Advisory panel: Neurology
Date received: 2016-03-02
Decision date: 2016-08-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fort Lauderdale, FL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code GZB

product code GZB

Death: 4
Injury: 1,879
Other: 2
Total: 1,885

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.