Cobra
Cobra: 5 catalogue numbers listed by Neurovision Medical Products, Inc., United States, under Stimulator, Electrical, Evoked Response. 3 manufacturers in China are registered for this product code.
3manufacturers in China registered for this device type
5catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Shandong (1), Shaanxi (1), Guangdong (1). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| Xian Friendship Medical Electronics Co., Ltd. | Xi’An | Shaanxi | Contract manufacturer | 10 |
| Shenzhen Launch Electrical Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 8 |
Record
| Listed by | Neurovision Medical Products, Inc., United States |
|---|---|
| FDA product code | GWF |
| Device type | Stimulator, Electrical, Evoked Response |
| Device class | Class 2 |
| Regulation | 21 CFR 882.1870 |
| Establishment | Manufacturer |
| 510(k) | K110989 |
| Record published | 2020-08-12 |
| Record revised | 2025-09-09 (version 3) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| N/A | 5 | In distribution | |
| N/A | 5 | In distribution | |
| N/A | 5 | In distribution | |
| N/A | 5 | In distribution | |
| N/A | 5 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Stimulator, Electrical, Evoked Response | Inomed Medizintechnik Gmbh | 170 |
| Alpine BioMed | Alpine Biomed Aps | 132 |
| Natus | Natus Neurology Incorporated | 98 |
| Keypoint | Natus Manufacturing Limited | 44 |
| Stimulator, Electrical, Evoked Response | Nihon Kohden America, Inc. | 41 |
| Stimulator, Electrical, Evoked Response | Nihon Kohden Corp. | 38 |
| Powerease™ Instruments | Medtronic Sofamor Danek, Inc. | 36 |
| Stimulator, Electrical, Evoked Response | Stryker Leibinger Gmbh & Co. KG | 29 |
| Natus | Xltek | 27 |
| Isis | Inomed Medizintechnik Gmbh | 26 |
| Xltek | Xltek | 24 |
| Natus Neurology | Natus Neurology Incorporated | 20 |
Showing 12 of 121. All products under Stimulator, Electrical, Evoked Response
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K110140 | 2011-09-30 |
Recalls Naming This Product
10 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Neurovision Medical Products, Inc. | 510(k) number | 2024-07-01 | Class II | Process control | mislabeling; EMG RLN monitoring kit labeling contains the incorrect tube size. | 5 BOXES (25 single kits) | |
| Neurovision Medical Products, Inc. | 510(k) number | 2020-07-21 | Class II | Under Investigation by firm | 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 transmissio | 1,089 | 2021-04-30 |
| Neurovision Medical Products, Inc. | 510(k) number | 2020-07-21 | Class II | Under Investigation by firm | 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 transmissio | 7,250 | 2021-04-30 |
| Neurovision Medical Products, Inc. | 510(k) number | 2020-07-21 | Class II | Under Investigation by firm | 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 transmissio | 1,239 | 2021-04-30 |
| Neurovision Medical Products, Inc. | 510(k) number | 2020-07-21 | Class II | Under Investigation by firm | 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 transmissio | 2021-04-30 | |
| Neurovision Medical Products, Inc. | 510(k) number | 2020-07-21 | Class II | Under Investigation by firm | 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 transmissio | 2021-04-30 | |
| Neurovision Medical Products, Inc. | 510(k) number | 2020-07-21 | Class II | Under Investigation by firm | 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 transmissio | 2021-04-30 | |
| Neurovision Medical Products, Inc. | 510(k) number | 2020-07-21 | Class II | Under Investigation by firm | 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 transmissio | 1,005 | 2021-04-30 |
| Neurovision Medical Products, Inc. | 510(k) number | 2020-07-21 | Class II | Under Investigation by firm | 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 transmissio | 3,425 | 2021-04-30 |
| Neurovision Medical Products, Inc. | 510(k) number | 2020-07-21 | Class II | Under Investigation by firm | 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 transmissio | 1,058 | 2021-04-30 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.