Stimulator Kit, Trial Kit, Spare Lead Kit, Wearable Assembly Kit— 510(k) K180981

Clearance details

Applicant

Stimwave Technologies Incorporated

Product code

Code GZB

Device class

Class 2

Regulation

21 CFR 882.5880

Advisory panel

Neurology

Date received

2018-04-13

Decision date

2018-09-19

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Pompano Beach, FL, US

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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 →