Stimulator Kit, Trial Kit, Spare Lead Kit, Wearable Assembly Kit— 510(k) K180981
Substantially EquivalentStimwave Technologies Incorporated
FDA 510(k) clearance K180981 for Stimulator Kit, Trial Kit, Spare Lead Kit, Wearable Assembly Kit, Substantially Equivalent on 2018-09-19. Applicant: Stimwave Technologies Incorporated.
Clearance details
- Applicant
- Stimwave Technologies Incorporated
- Product code
- 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.