Disposable EMG Needle Electrodes
122 catalogue numbers from TFDN351303SB, listed by Spes Medica Srl, Italy, under Electrode, Needle, Diagnostic Electromyograph. 2 manufacturers in China are registered for this product code.
2manufacturers in China registered for this device type
122catalogue numbers in this listing
1510(k) clearance
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 | Spes Medica Srl, Italy |
|---|---|
| FDA product code | IKT |
| Device type | Electrode, Needle, Diagnostic Electromyograph |
| Device class | Class 2 |
| Regulation | 21 CFR 890.1385 |
| Record published | 2016-06-27 |
| Record revised | 2025-02-21 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| TFDN351303SB | 20 | In distribution | |
| TFDN453730SB | 20 | In distribution | |
| NPSG30-P | 10 | In distribution | |
| TFDN452540SB | 20 | In distribution | |
| TFDN451801 | 10 | In distribution | |
| NG15W | In distribution | ||
| TFDN351340SB | 20 | In distribution | |
| TFDN351301SB | 20 | In distribution | |
| TFDN452501 | 10 | In distribution | |
| TFDN267545 | 25 | In distribution | |
| NG25P | In distribution | ||
| TFDN004537 | 20 | In distribution | |
| TFDN453741 | 10 | In distribution | |
| TFDN451840SB | 20 | In distribution | |
| NPEMG | In distribution | ||
| TFDN455030SB | 20 | In distribution | |
| TFDN452531 | 10 | In distribution | |
| TFDN451831SB | 20 | In distribution | |
| TFDN004550 | 20 | In distribution | |
| MIOBOT7570 | 10 | In distribution | |
| TFDN351330SB | 20 | In distribution | |
| NPSG30-N | 10 | In distribution | |
| NPSG0-R | 10 | In distribution | |
| TFDN455041SB | 20 | In distribution | |
| TFDN457540SB | 20 | In distribution | |
| D039035205 | 25 | In distribution | |
| TFDN455031SB | 20 | In distribution | |
| NG15P | In distribution | ||
| TFDN003537 | 20 | In distribution | |
| DSFN380453707 | 5 | In distribution | |
| NG25W | In distribution | ||
| TFDN455000SB | 20 | In distribution | |
| D0390302511 | 25 | In distribution | |
| NG25R | In distribution | ||
| NG15G | In distribution | ||
| TFDN457543SB | 20 | In distribution | |
| TFDN261500 | 25 | In distribution | |
| TFDN452503SB | 20 | In distribution | |
| TFDN263745 | 25 | In distribution | |
| TFDN452501SB | 20 | In distribution | |
| MIOBOT2540 | 10 | In distribution | |
| MIOBOT2530 | 10 | In distribution | |
| D039045401 | 25 | In distribution | |
| TFDN457500SB | 20 | In distribution | |
| TFDN455033 | 10 | In distribution | |
| NG25N | In distribution | ||
| TFDN351341 | 10 | In distribution | |
| TFDN453701 | 10 | In distribution | |
| TFDN453731 | 10 | In distribution | |
| TFDN453743 | 10 | In distribution | |
| TFDN455031 | 10 | In distribution | |
| TFDN351331SB | 20 | In distribution | |
| TFDN351333SB | 20 | In distribution | |
| TFDN452533SB | 20 | In distribution | |
| NG15N | In distribution | ||
| D039035408 | 25 | In distribution | |
| TFDN452543SB | 20 | In distribution | |
| TFDN4537503SB | 20 | In distribution | |
| TFDN351300SB | 20 | In distribution | |
| D039035302 | 25 | In distribution | |
| D039045504 | 25 | In distribution | |
| MIOBOT5050 | 10 | In distribution | |
| TFDN451841SB | 20 | In distribution | |
| TFDN455040SB | 20 | In distribution | |
| TFDN453743SB | 20 | In distribution | |
| TFDN453701SB | 20 | In distribution | |
| TFDN451831 | 10 | In distribution | |
| TFDN457531SB | 20 | In distribution | |
| NPSG30-R | 10 | In distribution | |
| TFDN452531SB | 20 | In distribution | |
| TFDN451841 | 10 | In distribution | |
| TFDN004575 | 20 | In distribution | |
| TFDN457501SB | 20 | In distribution | |
| NG15R | In distribution | ||
| TFDN457541SB | 20 | In distribution | |
| D0390453010 | 25 | In distribution | |
| TFDN262500 | 25 | In distribution | |
| D039050607 | 25 | In distribution | |
| NPSG0-N | 10 | In distribution | |
| TFDN451830SB | 20 | In distribution | |
| TFDN451833SB | 20 | In distribution | |
| NG25G | In distribution | ||
| TFDN455043SB | 20 | In distribution | |
| TFDN451801SB | 20 | In distribution | |
| TFDN455003SB | 20 | In distribution | |
| TFDN452541SB | 20 | In distribution | |
| TFDN455043 | 10 | In distribution | |
| TFDN452541 | 10 | In distribution | |
| TFDN457503SB | 20 | In distribution | |
| TFDN457530SB | 20 | In distribution | |
| TFDN263500 | 25 | In distribution | |
| TFDN452530SB | 20 | In distribution | |
| TFDN265045 | 25 | In distribution | |
| TFDN351301 | 10 | In distribution | |
| TFDN451800SB | 20 | In distribution | |
| NPSG0-B | 10 | In distribution | |
| NG25B | In distribution | ||
| TFDN264500 | 25 | In distribution | |
| MIOBOT3745 | 10 | In distribution | |
| TFDN351343SB | 20 | In distribution | |
| TFDN453703SB | 20 | In distribution | |
| TFDN452500SB | 20 | In distribution | |
| TFDN003525 | 20 | In distribution | |
| TFDN455001SB | 20 | In distribution | |
| D039035503 | 25 | In distribution | |
| D039060706 | 25 | In distribution | |
| TFDN351341SB | 20 | In distribution | |
| NPSG0-P | 10 | In distribution | |
| TFDN453700SB | 20 | In distribution | |
| NPSG30-B | 10 | In distribution | |
| NG15B | In distribution | ||
| TFDN451843SB | 20 | In distribution | |
| TFDN263700 | 25 | In distribution | |
| TFDN4537303SB | 20 | In distribution | |
| DSFN380452506 | 5 | In distribution | |
| TFDN453731SB | 20 | In distribution | |
| TFDN451803SB | 20 | In distribution | |
| TFDN455041 | 10 | In distribution | |
| TFDN453740SB | 20 | In distribution | |
| TFDN455033SB | 20 | In distribution | |
| TFDN351331 | 10 | In distribution | |
| TFDN453741SB | 20 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Technomed Europe | Technomed Engineering B.V. | 92 |
| Cadwell | Technomed Engineering B.V. | 42 |
| 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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K091410 | 2009-08-11 |
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.