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, Peripheral Nerve, Implanted (Pain Relief) (GZF) (10) Stimulator, Spinal-Cord, Implanted (Pain Relief) (GZB) (2)

Premarket Exempt

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StimQ Freedom-8A Spare Kit Channel B US w/Receiver - 00818225020761 Catalog Number :

Device Description : StimQ Peripheral Nerve Stimulator System StimQ Freedom-8A Spare Kit Channel B US StimQ Peripheral Nerve Stimulator System StimQ Freedom-8A Spare Kit Channel B US w/Receiver

Device Class : 2

Duns Number: 078294927

Premarket Exempt : No

Product Code : GZF

Prescription Use : Yes

Device Count : 1

StimQ Freedom-8A Spare Kit Channel A US w/ Receiver - 00818225020778 Catalog Number :

Device Description : StimQ Peripheral Nerve Stimulator System StimQ Freedom-8A Spare Kit Channel A US StimQ Peripheral Nerve Stimulator System StimQ Freedom-8A Spare Kit Channel A US w/ Receiver

Device Class : 2

Duns Number: 078294927

Premarket Exempt : No

Product Code : GZF

Prescription Use : Yes

Device Count : 1

StimQ Freedom-8A Trial Kit Channel B US w/ Receiver - 00818225020785 Catalog Number :

Device Description : StimQ Peripheral Nerve Stimulator System

Device Class : 2

Duns Number: 078294927

Premarket Exempt : No

Product Code : GZF

Prescription Use : Yes

Device Count : 1

StimQ Freedom-8A Trial Kit Channel A US w/ Receiver - 00818225020792 Catalog Number :

Device Description : StimQ Peripheral Nerve Stimulator System StimQ Freedom-8A Trial Kit Channel A US StimQ Peripheral Nerve Stimulator System StimQ Freedom-8A Trial Kit Channel A US w/ Receiver

Device Class : 2

Duns Number: 078294927

Premarket Exempt : No

Product Code : GZF

Prescription Use : Yes

Device Count : 1

StimQ Freedom-8A Receiver Kit Channel B US w/ Receiver - 00818225020808 Catalog Number :

Device Description : StimQ Peripheral Nerve Stimulator System StimQ Freedom-8A Receiver Kit Channel B StimQ Peripheral Nerve Stimulator System StimQ Freedom-8A Receiver Kit Channel B US w/ Receiver

Device Class : 2

Duns Number: 078294927

Premarket Exempt : No

Product Code : GZF

Prescription Use : Yes

Device Count : 1

StimQ Freedom-8A Receiver Kit Channel A US w/ Receiver - 00818225020815 Catalog Number :

Device Description : StimQ Freedom-8A Receiver Kit Channel A US w/ Receiver StimQ Peripheral Nerve St StimQ Freedom-8A Receiver Kit Channel A US w/ Receiver StimQ Peripheral Nerve Stimulator System

Device Class : 2

Duns Number: 078294927

Premarket Exempt : No

Product Code : GZF

Prescription Use : Yes

Device Count : 1

Wearable Antenna Assembly/StimQ Wearable Antenna Gear - 00818225020822 Catalog Number :

Device Description : Freedom Spinal Cord Stimulator System/StimQ Peripheral Nerve Stimulator System W Freedom Spinal Cord Stimulator System/StimQ Peripheral Nerve Stimulator System Wearable Antenna Assembly/StimQ Wearable Antenna Gear

Device Class : 2

Duns Number: 078294927

Premarket Exempt : No

Product Code : GZF, GZB

Prescription Use : Yes

Device Count : 1

Sterile Revision Kit - 00818225020839 Catalog Number :

Device Description : Freedom Spinal Cord Stimulator System/StimQ Peripheral Nerve Stimulator System S Freedom Spinal Cord Stimulator System/StimQ Peripheral Nerve Stimulator System Sterile Revision Kit

Device Class : 2

Duns Number: 078294927

Premarket Exempt : No

Product Code : GZF, GZB

Prescription Use : Yes

Device Count : 1

StimQ SWAG Accessory Kit Upper Arm - 00818225020846 Catalog Number :

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

Device Class : 2

Duns Number: 078294927

Premarket Exempt : No

Product Code : GZF

Prescription Use : Yes

Device Count : 1

StimQ SWAG Accessory Kit Lower Arm - 00818225020853 Catalog Number :

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

Device Class : 2

Duns Number: 078294927

Premarket Exempt : No

Product Code : GZF

Prescription Use : Yes

Device Count : 1

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