UltraPoint
DISPOSABLE ULTRAPOINT MONOPOLAR NEEDLE ELECTRODES: 28 GA., 45 MM NEEDLE, 2 FT. (0.6 M) SINGLE ORANGE LEADWIRE 25/Box
2manufacturers in China registered for this device type
9catalogue 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 | LifeSync Corporation, United States |
|---|---|
| FDA product code | IKT |
| Device type | Electrode, Needle, Diagnostic Electromyograph |
| Device class | Class 2 |
| Regulation | 21 CFR 890.1385 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K080914 |
| Record published | 2018-11-20 |
| Record revised | 2026-05-15 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Packaging | Pack of 25 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| NM-016388 | In distribution | ||
| NM-016395 | 25 | In distribution | |
| NM-016393 | 25 | In distribution | |
| NM-016391 | 25 | In distribution | |
| NM-016384 | 25 | In distribution | |
| NM-016380 | 25 | In distribution | |
| NM-016397 | 25 | In distribution | |
| NM-016383 | In distribution | ||
| NM-016386 | 25 | In distribution |
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 |
| 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 |
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.