Stimulator, Peripheral Nerve, Implanted (pain Relief)
Neurology · 21 CFR 882.5870
Recent MDR events
4,474 adverse event reports on file
- Freedom Peripheral Nerve StimulatorJul 31, 2026InjuryCuronix Llc3010676138-2026-00150
- Freedom Peripheral Nerve StimulatorJul 31, 2026InjuryCuronix Llc3010676138-2026-00151
- Freedom Peripheral Nerve StimulatorJul 30, 2026InjuryCuronix Llc3010676138-2026-00148
- StimRouterJul 30, 2026InjuryBioventus Llc3027669735-2026-00004
- TalisMannJul 30, 2026InjuryBioventus Llc3027669735-2026-00003
- Freedom Peripheral Nerve StimulatorJul 30, 2026InjuryCuronix Llc3010676138-2026-00149
- Freedom Peripheral Nerve StimulatorJul 29, 2026InjuryCuronix Llc3010676138-2026-00145
- Freedom Peripheral Nerve StimulatorJul 29, 2026InjuryCuronix Llc3010676138-2026-00146
- Nalu Neurostimulation SystemJul 29, 2026InjuryNalu Medical, Inc3015425075-2026-00070
- Freedom Peripheral Nerve StimulatorJul 29, 2026InjuryCuronix Llc3010676138-2026-00147
Event type breakdown
Recalls
7 recall events for this product code
- Nalu Medical, Inc.Open, ClassifiedJul 3, 2024
Neurostimulation Kit (Ported, Dual 8, 40 cm), REF: 71005-US
Neurostimulation Systems have a manufacturing non-conformance that may reduce the efficiency of the radiofrequency signals between the Implantable Pulse Generator (IPG) and the Therapy Disc, causing the IPG to be non-functional, which causes the device to be non-functional so it will no longer inhibit the transmission of pain signals to the brain.
Z-2257-2024 · View FDA record ↗ - Stimwave Technologies IncOpen, ClassifiedSep 2, 2020
StimQ Peripheral Nerve Stimulator System (PNS) Model 1. STQ4-RCV-A0 US and 2.STQ4-RCV-A0 EU - Product Usage: is used for peripheral neural stimulation to provi
The product contains a non-functional component not referenced in product labeling.
Z-2928-2020 · View FDA record ↗ - Stimwave Technologies IncOpen, ClassifiedSep 2, 2020
StimQ Peripheral Nerve Stimulator System (PNS) Model FR4A-TRL-AO US - Product Usage: is used for peripheral neural stimulation to provide therapeutic relief for
The product contains a non-functional component not referenced in product labeling.
Z-2929-2020 · View FDA record ↗ - Stimwave Technologies IncOpen, ClassifiedSep 2, 2020
StimQ Peripheral Nerve Stimulator System (PNS) Models: 1. FR4A-TRL-BO US and 2. FR4A-TR-BO - Product Usage: is used for peripheral neural stimulation to provid
The product contains a non-functional component not referenced in product labeling.
Z-2930-2020 · View FDA record ↗ - Stimwave Technologies IncOpen, ClassifiedSep 2, 2020
StimQ Peripheral Nerve Stimulator System (PNS) Models FR4A-SPR-BO US - Product Usage: is used for peripheral neural stimulation to provide therapeutic relief fo
The product contains a non-functional component not referenced in product labeling.
Z-2931-2020 · View FDA record ↗ - Stimwave Technologies IncOpen, ClassifiedSep 2, 2020
StimQ Peripheral Nerve Stimulator System (PNS) Model STQ4-SPR-BO US - Product Usage: is used for peripheral neural stimulation to provide therapeutic relief for
The product contains a non-functional component not referenced in product labeling.
Z-2932-2020 · View FDA record ↗ - Stimwave Technologies IncOpen, ClassifiedSep 2, 2020
StimQ Peripheral Nerve Stimulator System (PNS) Models: 1. FR4A-RCV-AO US and 2. FR4A-RCV-A0 EU - Product Usage: is used for peripheral neural stimulation to pr
The product contains a non-functional component not referenced in product labeling.
Z-2933-2020 · View FDA record ↗
Registered firms
57 firms currently registered for this product code
Abbott Medical
PLANO, TX, US
Ministim Corp
Boca Raton, FL, US
Pro-tech Design & Mfg, Inc.
Santa Fe Springs, CA, US
Isomedix Operations, Inc.
Minneapolis, MN, US
Isomedix Operations Inc.
S Plainfield, NJ, US
Resolution Medical
Minneapolis, MN, US
Curonix Llc
Pompano Beach, FL, US
Medtronic Puerto Rico Operations Co., Juncos
Juncos, PR, US
Bioventus Llc
Cordova, TN, US
Bioventus Llc
Durham, NC, US
Tegra Medical Costa Rica S.a.
La Aurora Heredia, CR
Medtronic Engineering And Innovation Center (meic)
Hyderabad Telangana, IN
Medtronic Puerto Rico Operations Co., Villalba
Villalba, PR, US
Midwest Sterilization Corp.
JACKSON, MO, US
Cirtec Medical
Brooklyn Park, MN, US
510(k) clearances
24 clearances for this product code
- Bioventus, LLCJul 16, 2025
K243782 · StimTrial Neuromodulation System
- Bioventus, LLCJul 3, 2025
K243678 · TalisMann Neuromodulation System
- Boston Scientific NeuromodulationAug 21, 2024
K232415 · Nalu Neurostimulation System for Peripheral Nerve Stimulation
- CuronixJun 20, 2024
K233162 · Freedom Peripheral Nerve Stimulator (PNS) System
- Neuspera Medical, Inc.Apr 11, 2023
K221303 · Neuspera Nuity System
- Bioness, Inc.Feb 23, 2022
K211965 · StimRouter Neuromodulation System
- Neuspera Medical, Inc.Aug 27, 2021
K202781 · Neuspera Neurostimulation System (NNS)
- Micron Medical CorporationAug 14, 2020
K200848 · Stimulator, Stimulator Kit, External Transmitter, External Transmitter Kit