Data / Medical devices / United States / Neurovision Medical Products, Inc.
Neurovision Medical Products, Inc.: FDA-registered device maker in Ventura, CA, United States, 7 510(k) clearances
Neurovision Medical Products, Inc. is registered with the FDA (registration 1930870) in Ventura, CA, United States. It lists 5 device types. The FDA files 7 510(k) clearances under its listings, the newest dated April 5, 2017. 4 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1930870
- Address
- 4837 Mcgrath St Unit B, Ventura, CA, United States, 93003
- Owner or operator
- NEUROVISION MEDICAL PRODUCTS, INC. (1930870)
- Roles
- Manufacturer
- First device listed
- January 9, 2007
- Registered through
- 2026
- Brand names listed
- Dragonfly Laryngeal Surface Electrode, LSE500 and LSE600 Series, Neurovision Ink Printed Endotracheal Tube Electrode, Scorpion Stimulating Instruments, Tadpole Hydrogel Electrode
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Cable, Electrode | IKD | 2 | Manufacturer | accessdata.fda.gov |
| Cystometric Gas (Carbon-Dioxide) On Hydraulic Device | FAP | 2 | Manufacturer | accessdata.fda.gov |
| Stimulator, Electrical, Evoked Response | GWF | 2 | Manufacturer | accessdata.fda.gov |
| Stimulator, Nerve | ETN | 2 | Manufacturer | accessdata.fda.gov |
| Tube, Tracheal (W/Wo Connector) | BTR | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| April 5, 2017 | K170677 | Neurovision Nerve Locator Monitor (Nerveana), EMGView Software | GWF | Substantially Equivalent | Neurovision Medical Product, Inc. | accessdata.fda.gov |
| December 13, 2012 | K113771 | SIGNAL GEAR URETHRAL CATHETER ELECTRODE | FAP | Substantially Equivalent | Neurovision Medical Products, Inc. | accessdata.fda.gov |
| October 19, 2012 | K121931 | NONDISPOSABLE STIMULATING INSTRUMENTS | ETN | Substantially Equivalent | Neurovision Medical Products, Inc. | accessdata.fda.gov |
| November 3, 2011 | K110989 | NEUROVISION INK PRINTED ENDOTRACHEAL TUBE ELECTRODE | ETN | Substantially Equivalent | Neurovision Medical Products, Inc. | accessdata.fda.gov |
| June 28, 2011 | K110712 | DRYTOUCH SUCTION STIMULATOR PROBE | ETN | Substantially Equivalent | Neurovision Medical Products, Inc. | accessdata.fda.gov |
| April 8, 2011 | K110138 | PAIRED HYDROGEL ELECTRODE | ETN | Substantially Equivalent | Neurovision Medical Products, Inc. | accessdata.fda.gov |
| January 16, 2001 | K003745 | LARYNGEAL SURFACE ELECTRODE-ENDOTRACHEAL TUBE, M-500-ET, LSE-ET | ETN | Substantially Equivalent | Rln Systems, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| May 19, 2025 | 96956 | Class II | Ongoing | Brand Name: Hummingbird Product Name: Stimulated EMG Kit with Hummingbird - Model/Catalog Number: REF I-D-BMF90, 1 Single-Use Bipolar Minifork Stimulation Probe, 90mm, and 1 Green Ground Needle; REF 1-D-BMF90-5, lot numb | Product packaging contains the wrong part number and kit contents. | accessdata.fda.gov |
| July 1, 2024 | 94931 | Class II | Ongoing | Cobra, 3-Plate EMG ET Tube, 6.0mm, REF: LTE7003PM, not made with natural rubber latex, Rx Only, STERILEEO | mislabeling; EMG RLN monitoring kit labeling contains the incorrect tube size. | accessdata.fda.gov |
| July 21, 2020 | 86102 | Class II | Terminated | Nerveana x5 RLN Monitoring Kit with Cobra 1-Ch EMG ET Tube, 6.0mm REF NVTKIT-C6-5, Rx Only, Sterile, UDI: B006NVTKITC652/$$7061918A - Product Usage: For continuous EMG monitoring and status assessment of the nerves suppl | The electrode insulating material on the Cobra EMG ET tube used for continuous EMG monitoring may soften over time so that it may be more susceptible to damage by scratching or bending, which could stop or inhibit the EMG signal transmission of the electrodes to the monitor and render the device not usable. | accessdata.fda.gov |
| January 11, 2010 | 54233 | Not yet classified | Terminated | 2-Channel Laryngeal Surface Electrode (Model LSE500DCS and LSE500DCL) For use as a Surgical stimulator/locator for recurrent laryngeal nerve. | This recall has been initiated due to a conductive glue used to attach the lead wire to electrode, which has been found in a small number of electrodes, to cause a short circuit in one of the channels. This is due to migration of the adhesive from one pad to the other creating an electrical short. Use of one of these defective electrodes could lead to a fail | accessdata.fda.gov |
Compare with other makers
- All makers of Cystometric Gas (Carbon-Dioxide) On Hydraulic Device
- All makers of Stimulator, Nerve
- All makers of Stimulator, Electrical, Evoked Response
- All makers of Tube, Tracheal (W/Wo Connector)
- All makers of Cable, Electrode
Updated July 9, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.