Cadwell
The kit consists of: • 1x Ground Electrode 40x50mm (302299-000-078), • 2x Twisted Pair Surface Electrode 20x25mm disk (302880-000), • White Subdermal Needle (302864-000), and • 8x Twisted…
The kit consists of: • 1x Ground Electrode 40x50mm (302299-000-078), • 2x Twisted Pair Surface Electrode 20x25mm disk (302880-000), • White Subdermal Needle (302864-000), and • 8x Twisted Subdermal Needles (white or black+ red, blue, purple, orange) (302868-000).
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 | Technomed Engineering B.V. |
|---|---|
| FDA product code | IKT |
| Device type | Electrode, Needle, Diagnostic Electromyograph |
| Device class | Class 2 |
| Regulation | 21 CFR 890.1385 |
| Record published | 2023-12-01 |
| Record revised | 2025-02-17 (version 5) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Shelf box of 25, shelf box of 10, box of 25, shelf box of 24, shelf box of 20 |
| Sizes | Outer diameter 0.3 to 0.7 mm; length 6 to 75 mm; needle gauge 22 to 30 G; length 1.2 m |
| Distribution end date | 2025-01-16 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 202250-000 | Needle Gauge 28 G | In distribution |
| 302862-000 | Needle Gauge 27 G | In distribution |
| 302363-000 | In distribution | |
| 302862-000-GP2 | Needle Gauge 27 G | In distribution |
| 202274-000 | Needle Gauge 26 G | In distribution |
| 302362-000 | In distribution | |
| 302882-000 | Needle Gauge 27 G | In distribution |
| 302865-000 | Length 18 mm | In distribution |
| 202454-000 | Needle Gauge 25 G | In distribution |
| 302867-000 | Length 13 mm | In distribution |
| 202254-000 | Needle Gauge 26 G | In distribution |
| 202271-000 | Outer Diameter 0.45 mm | In distribution |
| 202450-000 | Needle Gauge 30 G | In distribution |
| 302887-000 | Outer Diameter 0.38 mm | In distribution |
| 202451-000 | Length 25 mm | In distribution |
| 302364-000 | In distribution | |
| 202273-000 | Needle Gauge 26 G | In distribution |
| 302871-000 | Outer Diameter 0.38 mm | In distribution |
| 202452-000 | Needle Gauge 27 G | In distribution |
| 302886-000 | Outer Diameter 0.38 mm | In distribution |
| 202455-000 | Length 75 mm | In distribution |
| 202275-000 | Needle Gauge 26 G | In distribution |
| 302361-000 | In distribution | |
| 202253-000 | Needle Gauge 26 G | In distribution |
| 302868-000 | Length 13 mm | In distribution |
| 202272-000 | Needle Gauge 28 G | In distribution |
| 202453-000 | Length 37 mm | In distribution |
| 302884-000 | Outer Diameter 0.38 mm | In distribution |
| 302365-000 | In distribution | |
| 302366-000 | In distribution | |
| 202461-000 | Length 75 mm | In distribution |
| 302881-000 | In distribution | |
| 302863-000 | Needle Gauge 27 G | In distribution |
| 202457-000 | Length 25 mm | In distribution |
| 302866-000 | Length 13 mm | In distribution |
| 302864-000-GP2 | Needle Gauge 27 G | In distribution |
| 302872-000 | Needle Gauge 23 G | In distribution |
| 302864-000 | Needle Gauge 27 G | In distribution |
| 302870-000 | Length 7 mm | In distribution |
| 202459-000 | Length 37 mm | In distribution |
| 302869-000 | Length 13 mm | In distribution |
| 302870-000 | Length 6 mm | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Disposable EMG needle electrodes | Spes Medica Srl | 122 |
| Technomed Europe | Technomed Engineering B.V. | 92 |
| Chalgren | Chalgren Enterprises, Inc. | 42 |
| Rhythmlink® | Rhythmlink International, LLC | 39 |
| Electrode, Needle, Diagnostic Electromyograph | Neurovision Medical Products, Inc. | 38 |
| 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.