K180981
Substantially EquivalentStimulator Kit, Trial Kit, Spare Lead Kit, Wearable Assembly Kit
- Applicant
- Stimwave Technologies Incorporated
- Product code
- GZB
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Pompano Beach, FL, US
Adverse events under product code GZB
product code GZB- Death
- 4
- Injury
- 1,879
- Other
- 2
- Total
- 1,885
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.