Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, SWAG Kit, SWAG Accessory Kit, Charger Kit— 510(k) K171366

Substantially Equivalent

Stimwave Technologies Inc., Dba Stimq, LLC

FDA 510(k) clearance K171366 for Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, SWAG Kit, SWAG Accessory Kit, Charger Kit, Substantially Equivalent on 2017-08-04. Applicant: Stimwave Technologies Inc., Dba Stimq, LLC.

Clearance details

Applicant: Stimwave Technologies Inc., Dba Stimq, LLC
Product code: Code GZF
Advisory panel: Neurology
Date received: 2017-05-09
Decision date: 2017-08-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fort Lauderdale, FL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code GZF

product code GZF

Death: 10
Injury: 2,410
Other: 1
Total: 2,421

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.