Rhythmlink®
35 Detachable Monopolar Needle Electrodes, EMG, 37mm x 27g with 2 Detachable Reusable Adapter Cables
2manufacturers in China registered for this device type
39catalogue numbers in this listing
3510(k) clearances naming this product code
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 | Rhythmlink International, LLC, United States |
|---|---|
| FDA product code | IKT |
| Device type | Electrode, Needle, Diagnostic Electromyograph |
| Device class | Class 2 |
| Regulation | 21 CFR 890.1385 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| Record published | 2021-08-04 |
| Record revised | 2023-12-14 (version 2) |
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 | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date |
| Packaging | Product box of 10, product box of 20, product box of 25, product box of 50, pack of 10, product box of 48 |
| Sizes | Needle gauge 23 to 30 G |
| Distribution end date | 2025-08-06 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 242-3125-24TP | Needle Gauge 23 G | In distribution |
| EMGCNB50 | In distribution | |
| EMGCNG37 | In distribution | |
| 221-28SS-550 | Needle Gauge 25 G | In distribution |
| EMGCNV75 | In distribution | |
| EMGCNY25 | In distribution | |
| 121-812-24TP | Needle Gauge 28 G | In distribution |
| 221-28SS-375 | In distribution | |
| 242-725-24TP | Needle Gauge 27 G | In distribution |
| 111-737-8TP | Needle Gauge 27 G | In distribution |
| 115-737-29TP | Needle Gauge 27 G | In distribution |
| 115-725-29TP | Needle Gauge 27 G | In distribution |
| 111-637-24TP | Needle Gauge 26 G | In distribution |
| RLIEMG7 | Needle Gauge 27 G | In distribution |
| 242-550-24TP | Needle Gauge 25 G | In distribution |
| 110-737 | Needle Gauge 27 G | In distribution |
| 111-725-24TP | Needle Gauge 27 G | In distribution |
| EMGCNCOMBO | In distribution | |
| 242-550-24TP-25 | Needle Gauge 25 G | In distribution |
| 242-025-24TP-25 | Needle Gauge 30 G | In distribution |
| 242-025-24TP | Needle Gauge 30 G | In distribution |
| 110-725 | Needle Gauge 27 G | In distribution |
| 111-737-24TP | Needle Gauge 27 G | In distribution |
| 115-650-29TP | Needle Gauge 26 G | In distribution |
| 110-744 | Needle Gauge 27 G | In distribution |
| 110-650 | Needle Gauge 26 G | In distribution |
| 221-28SS-730 | Needle Gauge 27 G | In distribution |
| 242-375-24TP | Needle Gauge 23 G | In distribution |
| 242-725-24TP-25 | Needle Gauge 27 G | In distribution |
| 242-637-24TP | Needle Gauge 26 G | In distribution |
| 242-637-24TP-25 | Needle Gauge 26 G | In distribution |
| 111-837-24TP | Needle Gauge 28 G | In distribution |
| 110-637 | Needle Gauge 26 G | In distribution |
| 111-575-24TP | Needle Gauge 25 G | In distribution |
| 111-650-24TP | Needle Gauge 26 G | In distribution |
| 242-3100-24TP | Needle Gauge 23 G | In distribution |
| EMGCNR25 | In distribution | |
| 221-222SS-550 | Needle Gauge 25 G | Withdrawn |
| 111-4125-24TP | Needle Gauge 24 G | 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 |
| 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 |
|---|---|
| K120342 | 2012-06-22 |
| K091056 | 2009-06-23 |
| K091055 | 2009-06-23 |
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.