Stimulator, Nerve, Peripheral, Electric
NMT Sensor Cable 3.3M/11FT, 888414
5manufacturers in China registered for this device type
7catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangdong (3), Jiangsu (1), Tianjin (1). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Amphenol Medical Technologies (Dongguan) Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 77 |
| Shenzhen Launch Electrical Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 8 |
| Linxens Healthcare (Tianjin) Co., Ltd. | Jinnan District | Tianjin | Contract manufacturer | 7 |
| Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | Shenzhen | Guangdong | Specification developer | 61 |
| GE Medical Systems (China) Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 57 |
Record
| Listed by | GE Healthcare Finland OY, Finland |
|---|---|
| FDA product code | KOI |
| Device type | Stimulator, Nerve, Peripheral, Electric |
| Device class | Class 2 |
| Regulation | 21 CFR 868.2775 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| 510(k) | K051635 |
| Record published | 2016-06-16 |
| Record revised | 2024-10-14 (version 5) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Storage | Storage environment humidity 10 to 90 % RH; Handling environment temperature 10 to 40 °C; Storage environment atmospheric pressure 50 to 106 KiloPascal; Handling environment humidity 10 to 90 % RH; Storage environment temperature -20 to 60 °C; Handling environment atmospheric pressure 66 to 106 KiloPascal |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| NMT Pediatric MechanoSensor, 897439 | In distribution | |
| E-NMT-01 | In distribution | |
| NMT Sensor Cable 3.3m/11ft, 888414 | In distribution | |
| NMT ElectroSensor 0.3m/1ft, 888416 | In distribution | |
| NMT MechanoSensor, 888418 | In distribution | |
| NMT Regional Block Adapter, 888417 | In distribution | |
| NMT Electrodes, Solid Gel, Ag-AgCl | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| WiTOF | Idmed Corp. | 6 |
| TwitchView™ | Blink Device Company | 6 |
| Fisher & Paykel Healthcare | Fisher & Paykel Healthcare, Ltd. | 5 |
| Halyard | Avanos Medical, Inc. | 5 |
| Avanos | Avanos Medical, Inc. | 5 |
| Smart Cable NMT Module and Accessories | Nihon Kohden Corp. | 4 |
| Eye adapter TOF3D | Mipm Mammendorfer Institut für Physik und Medizin GmbH | 2 |
| TetraSens Pediatric | Senzime AB (Publ.) | 2 |
| Temperature sensor TOF3D | Mipm Mammendorfer Institut für Physik und Medizin GmbH | 2 |
| TetraGraph | Senzime AB (Publ.) | 2 |
| TetraSensitive | Senzime AB (Publ.) | 2 |
| Thumb adapter TOF3D | Mipm Mammendorfer Institut für Physik und Medizin GmbH | 2 |
Showing 12 of 61. All products under Stimulator, Nerve, Peripheral, Electric
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| GE Medical Systems, LLC | 510(k) number | 2014-04-09 | Class II | Software design | When the E-NMT-01 module is used in conjunction with the ElectroSensor, the Neuromuscular Transmission (NMT) values may indicate a deeper level of muscle relaxation than the actual level of muscle relaxation. In the clinical situation visua | 1,794 (471 units US, 1,323 units OUS) | 2015-09-28 |
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.