STIMWAVE TECHNOLOGIES INCORPORATED

Address:1310 Park Central Boulevard South,Pompano Beach,FL,33064,US

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Stimulator, Spinal-Cord, Implanted (Pain Relief) (GZB) (7) Stimulator, Peripheral Nerve, Implanted (Pain Relief) (GZF) (4)

Premarket Exempt

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StimQ SWAG Accessory Kit Torso - 00818225020860 Catalog Number :

Device Description : StimQ Peripheral Nerve Stimulator System StimQ SWAG Accessory Kit Torso

Device Class : 2

Duns Number: 078294927

Premarket Exempt : No

Product Code : GZF

Prescription Use : Yes

Device Count : 1

StimQ SWAG Accessory Kit Upper Leg - 00818225020877 Catalog Number :

Device Description : StimQ Peripheral Nerve Stimulator System StimQ SWAG Accessory Kit Upper Leg

Device Class : 2

Duns Number: 078294927

Premarket Exempt : No

Product Code : GZF

Prescription Use : Yes

Device Count : 1

StimQ SWAG Accessory Kit Lower Leg - 00818225020884 Catalog Number :

Device Description : StimQ Peripheral Nerve Stimulator System StimQ SWAG Accessory Kit Lower Leg

Device Class : 2

Duns Number: 078294927

Premarket Exempt : No

Product Code : GZF

Prescription Use : Yes

Device Count : 1

Battery Charger - 00818225020891 Catalog Number :

Device Description : Freedom Spinal Cord Stimulator System/StimQ Peripheral Nerve Stimulator System B Freedom Spinal Cord Stimulator System/StimQ Peripheral Nerve Stimulator System Battery Charger

Device Class : 2

Duns Number: 078294927

Premarket Exempt : No

Product Code : GZF, GZB

Prescription Use : Yes

Device Count : 1

Freedom Spinal Cord Stimulator System - 00859619004028 Catalog Number : WAA-A011

Device Description : Boogieboard Wearable Antenna Assembly 915

Device Class : 2

Duns Number: 078294927

Premarket Exempt : No

Product Code : GZB

Prescription Use : Yes

Device Count : 1

Freedom Spinal Cord Stimulator System - 00859619004035 Catalog Number : LBRD-915-2K

Device Description : Freedom Spinal Cord Stimulator System Longboard Wearable Antenna Assembly 915

Device Class : 2

Duns Number: 078294927

Premarket Exempt : No

Product Code : GZB

Prescription Use : Yes

Device Count : 1

Freedom Spinal Cord Stimulator System - 00859619004042 Catalog Number : S4R-1A US

Device Description : Freedom Spinal Cord Stimulator System Freedom-4A Receiver Kit Channel A US

Device Class : 2

Duns Number: 078294927

Premarket Exempt : No

Product Code : GZB

Prescription Use : Yes

Device Count : 1

Freedom Spinal Cord Stimulator System - 00859619004097 Catalog Number : S4T-1A US

Device Description : Freedom Spinal Cord Stimulator System Freedom-4A Trial Kit Channel A US

Device Class : 2

Duns Number: 078294927

Premarket Exempt : No

Product Code : GZB

Prescription Use : Yes

Device Count : 1

Freedom Spinal Cord Stimulator System - 00859619004103 Catalog Number : S4R-1B US

Device Description : Freedom Spinal Cord Stimulator System Freedom-4A Receiver Kit Channel B US

Device Class : 2

Duns Number: 078294927

Premarket Exempt : No

Product Code : GZB

Prescription Use : Yes

Device Count : 1

SandShark Injectable Anchor System - 00859619004202 Catalog Number :

Device Description : SandShark Injectable Anchor System

Device Class : 2

Duns Number: 078294927

Premarket Exempt : No

Product Code : GZB

Prescription Use : Yes

Device Count : 1

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