Electrode, Needle, Diagnostic Electromyograph
Electrode, Needle, Diagnostic Electromyograph: 38 catalogue numbers listed by Neurovision Medical Products, Inc., United States, under Electrode, Needle, Diagnostic Electromyograph. 2 manufacturers in China are registered for this product code.
2manufacturers in China registered for this device type
38catalogue numbers in this listing
Who Else Makes It
Concentrated in Shandong (1), Guangdong (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Pine Moon Electronics Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 8 |
| BIO Protech Yantai Inc | Yantai | Shandong | Manufacturer | 12 |
Record
| Listed by | Neurovision Medical Products, Inc., United States |
|---|---|
| FDA product code | IKT |
| Device type | Electrode, Needle, Diagnostic Electromyograph |
| Device class | Class 2 |
| Regulation | 21 CFR 890.1385 |
| Establishment | Manufacturer |
| 510(k) | K091410 |
| Record published | 2016-09-24 |
| Record revised | 2025-09-04 (version 10) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date |
| Packaging | Pack of 5 |
| Distribution end date | 2025-09-03 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| NONE | 5 | In distribution | |
| NONE | 5 | In distribution | |
| NONE | 5 | In distribution | |
| NONE | 5 | In distribution | |
| NONE | 5 | In distribution | |
| NONE | 5 | In distribution | |
| NONE | 5 | In distribution | |
| NONE | 5 | In distribution | |
| NONE | 5 | In distribution | |
| NONE | 5 | In distribution | |
| NONE | 5 | In distribution | |
| NONE | 5 | In distribution | |
| NONE | 5 | In distribution | |
| NONE | 5 | In distribution | |
| NONE | 5 | Withdrawn | |
| NONE | 10 | Withdrawn | |
| NONE | 5 | Withdrawn | |
| NONE | 5 | Withdrawn | |
| NONE | 5 | Withdrawn | |
| NONE | 5 | Withdrawn | |
| NONE | 5 | Withdrawn | |
| NONE | 5 | Withdrawn | |
| NONE | 5 | Withdrawn | |
| NONE | 5 | Withdrawn | |
| NONE | 5 | Withdrawn | |
| NONE | 5 | Withdrawn | |
| NONE | 5 | Withdrawn | |
| NONE | 5 | Withdrawn | |
| NONE | 10 | Withdrawn | |
| NONE | 5 | Withdrawn | |
| NONE | 5 | Withdrawn | |
| NONE | 5 | Withdrawn | |
| NONE | 5 | Withdrawn | |
| NONE | 5 | Withdrawn | |
| NONE | 5 | Withdrawn | |
| NONE | 5 | Withdrawn | |
| NONE | 5 | Withdrawn | |
| NONE | 5 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Disposable EMG needle electrodes | Spes Medica Srl | 122 |
| Technomed Europe | Technomed Engineering B.V. | 92 |
| Cadwell | Technomed Engineering B.V. | 42 |
| Chalgren | Chalgren Enterprises, Inc. | 42 |
| Rhythmlink® | Rhythmlink International, LLC | 39 |
| MediMax Tech | Medimax Tech Inc. | 19 |
| Bio Protech | BIO Protech USA, Inc. | 19 |
| UltraPoint™ | Rochester Electro Medical, Inc. | 18 |
| Bionen | Bionen SAS DI Barbara Nencioni & C. | 17 |
| Natus Neurology | Natus Neurology Incorporated | 13 |
| Neuroguard | Technomed Engineering B.V. | 11 |
| Teca Elite | Natus Manufacturing Limited | 11 |
Showing 12 of 39. All products under Electrode, Needle, Diagnostic Electromyograph
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.