Stimulator, Nerve, Battery-Powered
FDA product code BXN · Class II (moderate risk) · 21 CFR 868.2775 · Anesthesiology
63510(k) clearances
0PMA approvals
5recalls
Manufacturers
- Xavant Technology (Pty), Ltd. 6
- Biometer Intl. A/S 6
- Stockert GmbH 4
- Life-Tech Intl., Inc. 3
- Regional Master Corp. 3
- Singer Medical Products, Inc. 2
- C.R. Bard, Inc. 2
- Professional Instruments Co. 2
- Neuro Technology 2
- Prothia USA, Inc. 2
- PAJUNK GmbH Medizintechnologie 2
- Acm Systems 1
- National Medical Sales, Inc. 1
- Medar Corp., Inc. 1
- Fisher & Paykel Allied Products , Ltd. 1
- Output, Inc. 1
- Easy Med Instrument Co., Ltd. 1
- Beuro Technology 1
- Anesthesia Assoc., Inc. 1
- Intermedics, Inc. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K213049 | STIMPOD NMS450 Nerve StimulatorBXN · Traditional | Xavant Technology (Pty), Ltd. | 10/16/2022SE |
| K162086 | MultiStim ECOBXN · Traditional | PAJUNK GmbH Medizintechnologie | 01/06/2017SE |
| K153045 | SunStim Peripheral Nerve Stimulator/Sunstim Plus Peripheral Nerve StimulatorBXN · Special | Easy Med Instrument Co., Ltd. | 05/13/2016SE |
| K143095 | MiniStim MS-IVB Peripheral Nerve StimulatorBXN · Traditional | Halyard Health, Inc. | 03/24/2015SE |
| K140853 | Stimpod ST2-3010 Nerve StimulatorBXN · Special | Xavant Technology (Pty), Ltd. | 11/06/2014SE |
| K121743 | Easymed Peripheral Nerve Stimulator-SunstinBXN · Traditional | Sunmed, LLC | 03/28/2013SE |
| K111985 | Myoguide System Model 8008BXN · Traditional | Intronix Technologies Corp. | 12/30/2011SE |
| K110118 | Stimtrode Single Use Nerve StimulatorBXN · Special | Xavant Technology (Pty), Ltd. | 02/17/2011SE |
| K102084 | Stimpod NMS450 Nerve StimulatorBXN · Traditional | Xavant Technology (Pty), Ltd. | 12/16/2010SE |
| K093591 | Stimpod Model NMS-400 Nerve StimulatorBXN · Traditional | Xavant Technology (Pty), Ltd. | 12/03/2009SE |
| K091155 | AscendBXN · Traditional | Neurometrix, Inc. | 09/03/2009SE |
| K072092 | Xpod/Xmap Nerve StimulatorBXN · Traditional | Xavant Technology (Pty), Ltd. | 11/15/2007SE |
| K070134 | Modification to Stimuplex HNS-12, Model 4892098BXN · Special | Stockert GmbH | 03/22/2007SE |
| K062478 | ClavisBXN · Abbreviated | Medtronic A/S | 02/08/2007SE |
| K061983 | Stimuplex PenBXN · Abbreviated | Stockert GmbH | 11/21/2006SE |
| K061172 | Pajunk Multistim Sensor Nerve StimulatorsBXN · Traditional | PAJUNK GmbH Medizintechnologie | 10/17/2006SE |
| K052313 | Stimuplex HNS-12, Model 4892098BXN · Abbreviated | Stockert GmbH | 11/17/2005SE |
| K021033 | Stimuplex-Dig-Rc Nerve StimulatorBXN · Special | B.Braun Medical, Inc. | 03/21/2003SE |
| K011308 | MultistimBXN · Traditional | Pajunk GmbH | 11/29/2001SE |
| K990323 | Te Me Na Polystim Nerve StimilatorBXN · Traditional | Te ME NA S.A.R.L. | 09/28/2001SE |
| K003983 | Stimuplex HNS-11BXN · Traditional | Stockert GmbH | 06/06/2001SE |
| K954525 | Sensi-Touch Epidural Anesthesia FilterBXN · Traditional | Sherwood Medical Co. | 01/19/1996SE |
| K914164 | Vitalmax 840 SeriesBXN · Traditional | Pace Tech Medical Monitors, Inc. | 04/09/1993SE |
| K913184 | Ms-Iii MinistimBXN · Traditional | Life-Tech Intl., Inc. | 10/07/1991SE |
| K905092 | Neuromuscular Transmission MonitorBXN · Traditional | Utah Medical Products, Inc. | 06/25/1991SE |
| K904025 | Myotrack, Model HH 515BXN · Traditional | Myotrack Co. | 03/01/1991SE |
| K896368 | Modified AxostimBXN · Traditional | Singer Medical Products, Inc. | 11/27/1989SE |
| K892396 | Mini Accelograph Neuromuscular Trans. MonitorBXN · Traditional | Biometer Intl. A/S | 10/03/1989SE |
| K894786 | Bio-Industry Stim Poche(R)BXN · Traditional | The Hader Corp. | 09/29/1989SE |
| K893485 | Accelograph Neuromuscular Transmission MonitorBXN · Traditional | Biometer Intl. A/S | 07/28/1989SE |
| K890746 | Myotest DBS Nerve StimulatorBXN · Traditional | Biometer Intl. A/S | 07/14/1989SE |
| K883807 | AxostimBXN · Traditional | Singer Medical Products, Inc. | 02/09/1989SE |
| K883868 | Model NS242 Constant Current Peripheral Nerve StimBXN · Traditional | Fisher & Paykel Electronics , Ltd. | 11/28/1988SE |
| K881842 | TracerBXN · Traditional | Life-Tech Intl., Inc. | 08/31/1988SE |
| K882438 | Constant Current Peripheral Nerve Stim. #NS252BXN · Traditional | Fisher & Paykel Healthcare, Ltd. | 07/18/1988SE |
| K870619 | AccelographBXN · Traditional | Biometer Intl. A/S | 03/16/1987SE |
| K870338 | Model Ms-Ii MinistimBXN · Traditional | Life-Tech Intl., Inc. | 03/11/1987SE |
| K864830 | Teflon-Coated Hypodermic Needles/Regional BlockBXN · Traditional | Professional Instruments Co. | 01/12/1987SE |
| K864829 | Model NS-3CC Neuro-Stim Peripheral Nerve StimulatBXN · Traditional | Professional Instruments Co. | 01/12/1987SE |
| K862149 | Modified Neuromuscular Transmission MonitorBXN · Traditional | Puritan Bennett Corp. | 06/19/1986SE |
| K861935 | Model 100 Nerve StimulatorBXN · Traditional | National Medical Sales, Inc. | 06/13/1986SE |
| K860187 | Myograph 2000 - Neuro. Trans. Monitor & RecordingBXN · Traditional | Biometer Intl. A/S | 03/20/1986SE |
| K860186 | Myotest - Nerve StimulatorBXN · Traditional | Biometer Intl. A/S | 03/20/1986SE |
| K860126 | Stimuplex, Nerve StimulatorBXN · Traditional | Burron Medical Products, Inc. | 02/28/1986SE |
| K853422 | The GripperBXN · Traditional | Regional Master Corp. | 01/15/1986SE |
| K853477 | Nerve FinderBXN · Traditional | Regional Master Corp. | 01/14/1986SE |
| K853476 | T4 Monitor Stimulator ComputerBXN · Traditional | Regional Master Corp. | 01/14/1986SE |
| K853849 | Medar Apm Force TransducerBXN · Traditional | Medar Corp., Inc. | 01/03/1986SE |
| K852962 | Peripheral Nerve Stimulator Model A400BXN · Traditional | Fisher & Paykel Allied Products , Ltd. | 12/09/1985SE |
| K843175 | Nerve Stimulator Q10BXN · Traditional | Acm Systems | 08/20/1984SE |
| K830058 | Myograph 2000BXN · Traditional | Prothia USA, Inc. | 03/07/1983SE |
| K823583 | Myotest Nerve StimulatorBXN · Traditional | Prothia USA, Inc. | 12/30/1982SE |
| K822139 | StimpenBXN · Traditional | Neuro Technology | 09/13/1982SE |
| K822157 | Peripheral Nerve Stimulator, Model A-200BXN · Traditional | P.B. Services | 07/30/1982SE |
| K822138 | Neurostim IIBXN · Traditional | Neuro Technology | 07/30/1982SE |
| K822137 | Digistim IIBXN · Traditional | Beuro Technology | 07/30/1982SE |
| K811614 | Nerve Stimulator Model Aa 1050BXN · Traditional | Anesthesia Assoc., Inc. | 06/18/1981SE |
| K791442 | Bard Biomedical Nerve LocatorBXN · Traditional | C.R. Bard, Inc. | 09/19/1979SE |
| K791047 | Nerve Stimulator, Digital PeripheralBXN · Traditional | C.R. Bard, Inc. | 06/13/1979SE |
| K790123 | Stimulator, Battery PoweredBXN · Traditional | Intermedics, Inc. | 02/06/1979SE |
| K771765 | Myo-CheckBXN · Traditional | Med General | 09/30/1977SE |
| K771237 | Nerve StimulatorsBXN · Traditional | Rule Medical Instruments, Inc. | 08/02/1977SE |
| K760614 | Peripheral Nerve StimulatorBXN · Traditional | Output, Inc. | 11/19/1976SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2134-2024 Class II | Stimuplex A, 30 DEG, 22GX2", 0.70x50mm, Catalogue Number: 4894502The devices are labeled "not made with DEHP" or the DEHP free symbol; however, the glue used contains traces… | B Braun Medical Inc | 05/17/2024Open, Classified |
| Z-2133-2024 Class II | Stimuplex A, 30 DEG, 20GX6", 0.90x150mm, Catalogue Number: 4894278The devices are labeled "not made with DEHP" or the DEHP free symbol; however, the glue used contains traces… | B Braun Medical Inc | 05/17/2024Open, Classified |
| Z-2132-2024 Class II | Stimuplex A, 30 DEG, 21GX4", 0.80x100mm, Catalogue Number: 4894260The devices are labeled "not made with DEHP" or the DEHP free symbol; however, the glue used contains traces… | B Braun Medical Inc | 05/17/2024Open, Classified |
| Z-2131-2024 Class II | Stimuplex A, 30 DEG, 24GX1", 0.55x25mm, Catalogue Number: 4894251.The devices are labeled "not made with DEHP" or the DEHP free symbol; however, the glue used contains traces… | B Braun Medical Inc | 05/17/2024Open, Classified |
| Z-2360-2010 | Poly Stim II Nerve Stimulator 8 inch for use with Stryker Pain Pump, REF 550-100, Rx…Device may malfunction and lead to ineffective stimulation, which could delay finding the nerve and the… | Stryker Instruments Div. of Stryker… | 02/01/2010Terminated |