FDA.reportPublic FDA data

STIMWAVE TECHNOLOGIES INCORPORATED

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30106761383010676138STIMWAVE TECHNOLOGIES INCORPORATED1N2020-04-251310 Park Central Boulevard South Pompano Beach FL US 33064

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1666051095912128K182720Freedom Spinal Cord Stimulator (SCS) SystemGZB2019-03-29
1666051460980644K180981Stimulator Kit, Trial Kit, Spare Lead Kit, Wearable Assembly KitGZB2018-09-19
1666051882529022K172644Sandshark Injectable Anchor Kit, Injectroducer Handle, Loading Rod with Anchor, Loading BaseGZB2017-11-03
1666051172104415K171366Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, SWAG Kit, SWAG Accessory Kit, Charger KitGZF2017-08-04
1666051640121471K170141Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, Wearable Antenna Assembly Kit and Charger KitGZB2017-05-02
1666051761732375K162161Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, Wearable Antenna Assembly Kit and Charger KitGZB2016-12-16
1666051187429135K160600Freedom Spinal Cord Stimulator SystemGZB2016-08-26
1666051915818580K152178StimQ Peripheral Nerve Stimulator (PNS) SystemGZF2016-03-11
1666051846794106K150517Freedom Spinal Cord Stimulator SystemGZB2015-06-05
1666051016679934K141399FREEDOM SPINAL CORD STIMULATOR (SCS) SYSTEMGZB2014-10-10

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
GZB82019-03-29
GZF22017-08-04

PMN#

GUDID#

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