Cobra®
Cobra®: 4 catalogue numbers listed by Neurovision Medical Products, Inc., United States, under Stimulator, Nerve. 8 manufacturers in China are registered for this product code.
8manufacturers in China registered for this device type
4catalogue numbers in this listing
5510(k) clearances naming this product code
12recalls on this code
Who Else Makes It
Concentrated in Zhejiang (2), Jiangsu (2), Guangdong (2). 6 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 |
| Forefront Medical Technology (Jiangsu) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 14 |
| Xian Friendship Medical Electronics Co., Ltd. | Xi’An | Shaanxi | Contract manufacturer | 10 |
| Ningbo Shun YE Medical Company, Ltd. | Cixi Ningbo | Zhejiang | Contract manufacturer | 8 |
| Shenzhen Launch Electrical Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 8 |
| Pine Moon Electronics Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 8 |
| Goals Sterilization Co., Ltd. | Jiaxing | Zhejiang | Contract manufacturer | 26 |
| Changzhou Emanmed Biotechnology Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 4 |
Record
| Listed by | Neurovision Medical Products, Inc., United States |
|---|---|
| FDA product code | ETN |
| Device type | Stimulator, Nerve |
| Device class | Class 2 |
| Regulation | 21 CFR 874.1820 |
| Establishment | Manufacturer |
| 510(k) | K110989 |
| Record published | 2023-03-20 |
| Record revised | 2025-09-09 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Packaging | Pack of 5 |
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 |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| ReLine | Nuvasive, Inc. | 226 |
| Stimulator, Nerve | Medtronic Xomed, Inc. | 125 |
| MaXcess | Nuvasive, Inc. | 95 |
| Armada | Nuvasive, Inc. | 67 |
| Stimulator, Nerve | Neurovision Medical Products, Inc. | 47 |
| Precept | Nuvasive, Inc. | 39 |
| MAS Plif | Nuvasive, Inc. | 36 |
| NIM | Medtronic Xomed, Inc. | 34 |
| Nerveana® | Neurovision Medical Products, Inc. | 30 |
| SpheRx | Nuvasive, Inc. | 30 |
| IOM Stimulator Probes | Spes Medica Srl | 29 |
| NVM5 | Nuvasive, Inc. | 25 |
Showing 12 of 119. All products under Stimulator, Nerve
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K121931 | 2012-10-19 |
| K110989 | 2011-11-03 |
| K110712 | 2011-06-28 |
| K110138 | 2011-04-08 |
| K102862 | 2010-12-21 |
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 |
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2025-05-19 | Class II | Process control | Product packaging contains the wrong part number and kit contents. | 10 | |
| 2010-01-11 | Not classified | Other | 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 adhesi | 4143 | 2011-04-21 |
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.