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Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, Wearable Antenna…

FDA 510(k)

Class II (US FDA 510(k))

510(k) K170141

by Stimwave Technologies Incorporated

Identifiers

510(k) Number
K170141 FDA 510(k)
FDA Product Code
GZB FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 882.5880 FDA 510(k)
Regulation Number
882.5880 FDA 510(k)
Advisory Committee
Neurology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Receiver Kit is a collection of components for a spinal cord stimulator system, including a receiver component, wearable antenna assembly, charger, and various kits for trial, spare leads, and sterile revision procedures. This system is designed for implantation to provide pain relief through electrical stimulation.

The device is supplied as sterile and is intended for single use. It is classified under product code GZB and received FDA 510(k) clearance with number K170141 on May 2, 2017, as substantially equivalent. The device is regulated under 882.5880 and is manufactured by Stimwave Technologies Incorporated.

Frequently asked questions

What components are included in the Stimwave Receiver Kit?

The Receiver Kit contains a receiver component, wearable antenna assembly, charger, and various kits for trial procedures, spare leads, and sterile revision procedures. This collection is designed for implantation to provide pain relief through electrical stimulation.

Is the Receiver Kit sterile and can it be reused?

The Receiver Kit is supplied as sterile and is intended for single use only. It should not be reused or resterilized as this could compromise the device's integrity and safety.

What is the regulatory status of the Stimwave Receiver Kit?

The device received FDA 510(k) clearance with number K170141 on May 2, 2017, as substantially equivalent. It is classified under product code GZB and regulated under 882.5880.

What is the purpose of the Stimwave Receiver Kit?

The Receiver Kit is designed for implantation as part of a spinal cord stimulator system to provide pain relief through electrical stimulation. It includes all necessary components for trial, implantation, and revision procedures.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, Wearable ..., PDF Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, Wearable ..., Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, SWAG Kit ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Stimwave Technologies Incorporated

Sources (1)

  • FDA 510(k) K170141 24 fields · synced Sep 28, 2026