Browse hierarchy: [Neurology (NE)](/submissions/NE) → [Subpart F — Neurological Therapeutic Devices](/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices) → [21 CFR 882.5870](/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/882.5870) → GZF — Stimulator, Peripheral Nerve, Implanted (Pain Relief) # GZF · Stimulator, Peripheral Nerve, Implanted (Pain Relief) _Neurology · 21 CFR 882.5870 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GZF ## Overview - **Product Code:** GZF - **Device Name:** Stimulator, Peripheral Nerve, Implanted (Pain Relief) - **Regulation:** [21 CFR 882.5870](/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/882.5870) - **Device Class:** 2 - **Review Panel:** [Neurology](/submissions/NE) - **Implant:** yes ## Identification An implanted peripheral nerve stimulator for pain relief is a device that is used to stimulate electrically a peripheral nerve in a patient to relieve severe intractable pain. The stimulator consists of an implanted receiver with electrodes that are placed around a peripheral nerve and an external transmitter for transmitting the stimulating pulses across the patient's skin to the implanted receiver. ## Classification Rationale Class II (performance standards). ## Recent Cleared Devices (20 of 25) Showing 20 most recent of 25 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K240974](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GZF/K240974.md) | SPRINT PNS System | Spr Therapeutics, Inc. | Apr 14, 2026 | SESE | | [K243782](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GZF/K243782.md) | StimTrial Neuromodulation System | Bioventus, LLC | Jul 16, 2025 | SESE | | [K243678](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GZF/K243678.md) | TalisMann Neuromodulation System | Bioventus, LLC | Jul 3, 2025 | SESE | | [K232415](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GZF/K232415.md) | Nalu Neurostimulation System for Peripheral Nerve Stimulation | Boston Scientific Neuromodulation | Aug 21, 2024 | SESE | | [K233162](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GZF/K233162.md) | Freedom Peripheral Nerve Stimulator (PNS) System | Curonix | Jun 20, 2024 | SESE | | [K221303](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GZF/K221303.md) | Neuspera Nuity System | Neuspera Medical, Inc. | Apr 11, 2023 | SESE | | [K211965](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GZF/K211965.md) | StimRouter Neuromodulation System | Bioness, Inc. | Feb 23, 2022 | SESE | | [K202781](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GZF/K202781.md) | Neuspera Neurostimulation System (NNS) | Neuspera Medical, Inc. | Aug 27, 2021 | SESE | | [K200848](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GZF/K200848.md) | Stimulator, Stimulator Kit, External Transmitter, External Transmitter Kit | Micron Medical Corporation | Aug 14, 2020 | SESE | | [K200482](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GZF/K200482.md) | StimRouter Neuromodulation System | Bioness, Inc. | Mar 27, 2020 | SESE | | [K190047](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GZF/K190047.md) | StimRouter Neuromodulation System | Bioness, Inc. | Oct 31, 2019 | SESE | | [K191435](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GZF/K191435.md) | IPG, integrated, 25/40 cm, single, tined, IPG, 2 cm, single 4, Lead (25/40 cm, 4, tined), Extension - 4 | Nalu Medical, Inc. | Sep 6, 2019 | SESE | | [K183579](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GZF/K183579.md) | Nalu Neurostimulation Kit (Integrated, 40 cm: Single 8/Dual 8), Nalu Neurostimulation Kit (Ported, 2 cm: Single 8/Dual 8), Dual 8 Ported Nalu Implantable Pulse Generator with 40 cm Kit, 40 cm/ 60 cm Trial/Extension Lead Kits, Patient Kits and miscellaneous replacement kits | Boston Scientific Neuromodulation | Mar 29, 2019 | SESE | | [K171366](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GZF/K171366.md) | Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, SWAG Kit, SWAG Accessory Kit, Charger Kit | Stimwave Technologies Inc., Dba Stimq, LLC | Aug 4, 2017 | SESE | | [K152178](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GZF/K152178.md) | StimQ Peripheral Nerve Stimulator (PNS) System | Stimq, LLC | Mar 11, 2016 | SESE | | [K142432](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GZF/K142432.md) | StimRouter Lead Kit/StimRouter Surgical Tool Kit/StimRouter Clinician Kit/StimRouter User Kit | Bioness, Inc. | Feb 20, 2015 | SESE | | [K000852](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GZF/K000852.md) | RENEW NEUROSTIMULATION SYSTEM | Advanced Neuromodulation Systems | Jan 19, 2001 | SESE | | [K000105](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GZF/K000105.md) | MEDTRONIC EXTENSION PASSER TUNNELING SYSTEM (38 CM), MODEL 3555-38; MEDTRONIC EXTENSION PASSER TUNNELING SYSTEM (60 CM), | Medtronic Vascular | Apr 12, 2000 | SESE | | [K982902](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GZF/K982902.md) | PERIPHERAL NERVE STIMULATION | Medtronic Vascular | Nov 10, 1998 | SESE | | [K960631](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GZF/K960631.md) | MEDTRONIC MODEL 3550 ACCESSORY KIT (CONTENTS) 3550-OX | Medtronic Vascular | May 21, 1996 | SESE | ## Top Applicants - Medtronic Vascular — 8 clearances - Bioness, Inc. — 4 clearances - Bioventus, LLC — 2 clearances - Boston Scientific Neuromodulation — 2 clearances - Neuspera Medical, Inc. — 2 clearances --- **Source:** [https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GZF](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GZF) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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