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 IDK141399
510k NumberK141399
Device Name:FREEDOM SPINAL CORD STIMULATOR (SCS) SYSTEM
ClassificationStimulator, Spinal-cord, Implanted (pain Relief)
Applicant STIMWAVE TECHNOLOGIES INCORPORATED 420 Lincoln Rd Suite 365 Miami Beach,  FL  33139
ContactElizabeth Greene
CorrespondentElizabeth Greene
STIMWAVE TECHNOLOGIES INCORPORATED 420 Lincoln Rd Suite 365 Miami Beach,  FL  33139
Product CodeGZB  
CFR Regulation Number882.5880 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-05-28
Decision Date2014-10-10
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00859619004028 K141399 000
40859619004026 K141399 000

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