510(k) K162161 · GZB Stimulator, Spinal-Cord, Implanted (Pain Relief)

Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, Wearable Antenna Assembly Kit and Charger Kit

Applicant	Stimwave Technologies Incorporated, Fort Lauderdale FL, US
Decision	Substantially Equivalent, Dec 16, 2016
Received	Aug 2, 2016
Type	Traditional
FDA record	Open on fda.gov

Recalls that name K162161

No recall in the FDA data names this 510(k).

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.