BEUDAMED
    Product Code: GZF FDA class 2 21 CFR 882.5870

    Stimulator, Peripheral Nerve, Implanted (Pain Relief)

    Neurology

    The Implanted Peripheral Nerve Stimulator for Pain Relief is a surgically implanted neuromodulation device that delivers electrical impulses to peripheral nerves to manage chronic pain conditions that have not responded to other treatments. It is classified as a Class 2 device (moderate risk), requiring 510(k) premarket notification, and is designated as an implant. The product code is GZF under regulation 21 CFR 882.5870 in the Neurology specialty. The implant flag is active for this device.

    View on FDA
    510(k)s
    24
    FEI Numbers
    26
    Registration Numbers
    26
    Unique Applicants
    11
    Years Active
    34

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    Basic Information

    Product Code
    GZF
    Device Class
    FDA class 2
    Regulation Number
    882.5870
    Medical Specialty
    Neurology
    Review Panel
    NE
    Submission Type
    1

    Device Characteristics

    ✗
    GMP Exempt
    ✓
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 24 510(k) clearances via K numbers.

    K Number Device Name
    K243782 StimTrial Neuromodulation System
    K243678 TalisMann Neuromodulation System
    K232415 Nalu Neurostimulation System for Peripheral Nerve Stimulation
    K233162 Freedom Peripheral Nerve Stimulator (PNS) System
    K221303 Neuspera Nuity System
    K211965 StimRouter Neuromodulation System
    K202781 Neuspera Neurostimulation System (NNS)
    K200848 Stimulator, Stimulator Kit, External Transmitter, External Transmitter Kit
    K200482 StimRouter Neuromodulation System
    K190047 StimRouter Neuromodulation System
    K191435 IPG, integrated, 25/40 cm, single, tined, IPG, 2 cm, single 4, Lead (25/40 cm, 4, tined), Extension - 4
    K183579 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
    K171366 Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, SWAG Kit, SWAG Accessory Kit, Charger Kit
    K152178 StimQ Peripheral Nerve Stimulator (PNS) System
    K142432 StimRouter Lead Kit/StimRouter Surgical Tool Kit/StimRouter Clinician Kit/StimRouter User Kit
    K000852 RENEW NEUROSTIMULATION SYSTEM
    K000105 MEDTRONIC EXTENSION PASSER TUNNELING SYSTEM (38 CM), MODEL 3555-38; MEDTRONIC EXTENSION PASSER TUNNELING SYSTEM (60 CM),
    K982902 PERIPHERAL NERVE STIMULATION
    K960631 MEDTRONIC MODEL 3550 ACCESSORY KIT (CONTENTS) 3550-OX
    K950425 TECOTHANE 55D
    K925952 MEDTRONIC MODEL 3990 PNS LEAD
    K920567 MODELS 3987 AND 3988 RESUME LEAD FOR PNS
    K915540 MODEL 3587A RESUME II LEAD
    K904409 MEDTRONIC(R) MODEL 3470 X-TREL(TM) RECEIVER

    FEI Numbers

    This FDA classification entry is associated with 26 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 26 registration numbers. Click on an entry to view related FDA registrations.