Avanos
EZstim* Peripheral Nerve Stimulator/Nerve Locator
5manufacturers in China registered for this device type
5catalogue 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 | Avanos Medical, Inc., United States |
|---|---|
| FDA product code | KOI |
| Device type | Stimulator, Nerve, Peripheral, Electric |
| Device class | Class 2 |
| Regulation | 21 CFR 868.2775 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K162048 |
| Record published | 2020-05-07 |
| Record revised | 2022-09-23 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
| Distribution end date | 2022-08-01 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 39253 | In distribution | |
| 39198 | In distribution | |
| 44735 | In distribution | |
| 44736 | In distribution | |
| 39197 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Stimulator, Nerve, Peripheral, Electric | GE Healthcare Finland OY | 7 |
| WiTOF | Idmed Corp. | 6 |
| TwitchView™ | Blink Device Company | 6 |
| Fisher & Paykel Healthcare | Fisher & Paykel Healthcare, Ltd. | 5 |
| Halyard | 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
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.