Ares 620 Unicorder System
ARES 620 HST Recorder and Disposables
8manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Zhejiang (2), Jiangsu (2), Guangdong (2). 6 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| Forefront Medical Technology (Jiangsu) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 14 |
| Xian Friendship Medical Electronics Co., Ltd. | Xi’An | Shaanxi | Contract manufacturer | 10 |
| Ningbo Shun YE Medical Company, Ltd. | Cixi Ningbo | Zhejiang | Contract manufacturer | 8 |
| Shenzhen Launch Electrical Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 8 |
| Pine Moon Electronics Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 8 |
| Goals Sterilization Co., Ltd. | Jiaxing | Zhejiang | Contract manufacturer | 26 |
| Changzhou Emanmed Biotechnology Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 4 |
Record
| Listed by | Watermark Medical Inc, United States |
|---|---|
| FDA product code | ETN |
| Device type | Stimulator, Nerve |
| Device class | Class 2 |
| Regulation | 21 CFR 874.1820 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K160499 |
| Record published | 2017-05-19 |
| Record revised | 2023-12-18 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Storage | Special storage condition: Keep Dry; Storage environment temperature 15 to 40 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 620 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| ReLine | Nuvasive, Inc. | 226 |
| Stimulator, Nerve | Medtronic Xomed, Inc. | 125 |
| MaXcess | Nuvasive, Inc. | 95 |
| Armada | Nuvasive, Inc. | 67 |
| Stimulator, Nerve | Neurovision Medical Products, Inc. | 47 |
| Precept | Nuvasive, Inc. | 39 |
| MAS Plif | Nuvasive, Inc. | 36 |
| NIM | Medtronic Xomed, Inc. | 34 |
| Nerveana® | Neurovision Medical Products, Inc. | 30 |
| SpheRx | Nuvasive, Inc. | 30 |
| IOM Stimulator Probes | Spes Medica Srl | 29 |
| NVM5 | Nuvasive, Inc. | 25 |
Showing 12 of 119. All products under Stimulator, Nerve
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.