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Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, SWAG Kit, SWAG Accessory Kit, Charger Kit

by Stimwave Technologies Inc., Dba Stimq, LLC

510(k) K171366

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

6 ongoing

This device is named in the recall

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK171366 Date4 Aug 2017ClearedStatusActive

Recalls

6 recalls · 6 ongoing · FDA

  • 6 recalls, same reason

    • Ongoing Z-2929-2020 FDA Class II initiated 15 Jul 2020
    • Ongoing Z-2930-2020 FDA Class II initiated 15 Jul 2020
    • Ongoing Z-2932-2020 FDA Class II initiated 15 Jul 2020
    • Ongoing Z-2928-2020 FDA Class II initiated 15 Jul 2020
    • Ongoing Z-2931-2020 FDA Class II initiated 15 Jul 2020
    • Ongoing Z-2933-2020 FDA Class II initiated 15 Jul 2020

    The product contains a non-functional component not referenced in product labeling.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
GZF
Device Class
Class II
Regulation
21 CFR Part 882.5870
Advisory Committee
Neurology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 26 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Receiver Kit is a collection of components for peripheral nerve stimulation devices used for pain relief. It includes trial kits, spare leads, sterile revision kits, SWAG kits, SWAG accessory kits, and charger kits. This device is classified as an implanted stimulator for peripheral nerve stimulation.

The Receiver Kit is supplied as sterile and is intended for single use. It is used for trial stimulation lasting no longer than 30 days to determine efficacy before recommendation for a permanent device. The device has FDA 510(k) clearance with product code GZF and regulation number 882.5870.

Questions

AI-generated answers, 26 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the purpose of the Receiver Kit?

    The Receiver Kit is a collection of components for peripheral nerve stimulation devices used for pain relief. It includes trial kits, spare leads, sterile revision kits, SWAG kits, SWAG accessory kits, and charger kits.

  • Is the Receiver Kit reusable or single-use?

    The Receiver Kit is supplied as sterile and is intended for single use. It is specifically designed for trial stimulation lasting no longer than 30 days to determine efficacy before recommendation for a permanent device.

  • What regulatory approvals does the Receiver Kit have?

    The Receiver Kit has FDA 510(k) clearance with product code GZF and regulation number 882.5870. It is classified as an implanted stimulator for peripheral nerve stimulation.

  • What components are included in the Receiver Kit?

    The Receiver Kit includes trial kits, spare leads, sterile revision kits, SWAG kits, SWAG accessory kits, and charger kits, all designed for use with peripheral nerve stimulation devices for pain relief.