Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, Wearable Antenna Assembly Kit and Charger Kit— 510(k) K170141

Clearance details

Applicant

Stimwave Technologies Incorporated

Product code

Code GZB

Device class

Class 2

Regulation

21 CFR 882.5880

Advisory panel

Neurology

Date received

2017-01-17

Decision date

2017-05-02

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Fort Lauderdale, 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 →