Freedom Spinal Cord Stimulator (SCS) System

Stimulator, Spinal-cord, Implanted (pain Relief)

Stimwave Technologies Incorporated

The following data is part of a premarket notification filed by Stimwave Technologies Incorporated with the FDA for Freedom Spinal Cord Stimulator (scs) System.

Pre-market Notification Details

Device IDK182720
510k NumberK182720
Device Name:Freedom Spinal Cord Stimulator (SCS) System
ClassificationStimulator, Spinal-cord, Implanted (pain Relief)
Applicant Stimwave Technologies Incorporated 1310 Park Central Boulevard South Pompano Beach,  FL  33064
ContactElizabeth Greene
CorrespondentElizabeth Greene
Stimwave Technologies Inc. 1310 Park Central Boulevard South Pompano Beach,  FL  33064
Product CodeGZB  
CFR Regulation Number882.5880 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-09-28
Decision Date2019-03-29

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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