Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, Wearable Antenna Assembly Kit and Charger Kit— 510(k) K162161

Substantially Equivalent

Stimwave Technologies Incorporated

FDA 510(k) clearance K162161 for Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, Wearable Antenna Assembly Kit and Charger Kit, Substantially Equivalent on 2016-12-16. Applicant: Stimwave Technologies Incorporated.

Clearance details

Applicant: Stimwave Technologies Incorporated
Product code: Code GZB
Advisory panel: Neurology
Date received: 2016-08-02
Decision date: 2016-12-16
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.