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Stimwave Technologies Incorporated

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
8
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K182720Freedom Spinal Cord Stimulator (SCS) SystemMarch 29, 2019
K180981Stimulator Kit, Trial Kit, Spare Lead Kit, Wearable Assembly KitSeptember 19, 2018
K172644Sandshark Injectable Anchor Kit, Injectroducer Handle, Loading Rod with Anchor, Loading BaseNovember 3, 2017
K170141Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, Wearable Antenna Assembly Kit and ChaMay 2, 2017
K162161Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, Wearable Antenna Assembly Kit and ChaDecember 16, 2016
K160600Freedom Spinal Cord Stimulator SystemAugust 26, 2016
K150517Freedom Spinal Cord Stimulator SystemJune 5, 2015
K141399FREEDOM SPINAL CORD STIMULATOR (SCS) SYSTEMOctober 10, 2014