Saberwave/ECO Microwave Therapeutic System
The Microwave Therapeutic System consists of microwave source, control system, display system and temperature measurement system. It is a software-controlled microwave generator that…
The Microwave Therapeutic System consists of microwave source, control system, display system and temperature measurement system. It is a software-controlled microwave generator that deliver the microwave energy at a working frequency of 2450 MHz.
Who Else Makes It
Concentrated in Jiangsu (6), Shanghai (2), Zhejiang (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Sterigenics Shanghai ETO Ltd. | Shanghai | Shanghai | Contract manufacturer | 65 |
| Micro-Tech (Nanjing) Co., Ltd. | Nan Jing | Jiangsu | Contract manufacturer | 49 |
| Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. | Cixi | Zhejiang | Manufacturer | 8 |
| Covidien Medical Products (Shanghai) Manufacturing LLC | Shanghai | Shanghai | Contract manufacturer | 8 |
| Canyon Medical Inc. | Nanjing | Jiangsu | Manufacturer | 4 |
| Hygea Medical Technology Co., Ltd. | Beijing | Beijing | Manufacturer | 2 |
| Betters(Suzhou) Medical Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 1 |
| Nanjing Devin Medical Technology Co., Ltd. | Nanjing | Jiangsu | Manufacturer | 1 |
| ECO Medical Technology (Nanjing) Co., Ltd. | Nanjing | Jiangsu | Manufacturer | 1 |
| Mima-PRO (NAN Tong) Scientific Inc. | Nantong | Jiangsu | Manufacturer | 1 |
Record
| Listed by | ECO Medical Technology (Nanjing) Co., Ltd., China |
|---|---|
| FDA product code | NEY |
| Device type | System, Ablation, Microwave And Accessories |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4400 |
| Establishment | Manufacturer, Exporter |
| 510(k) | K201262 |
| Record published | 2022-11-02 |
| Record revised | 2023-10-18 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | expiry date, serial number |
| Distribution end date | 2022-12-02 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SABERWAVE ECO-200G | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Microwave Ablation Antennas | Canyon Medical Inc. | 66 |
| Neuwave | Neuwave Medical, Inc. | 25 |
| ECO Disposable microwave therapeutic antenna | ECO Medical Technology (Nanjing) Co., Ltd. | 21 |
| Hygea | Hygea Medical Technology Co., Ltd. | 18 |
| Avecure | MedWaves, Inc | 17 |
| Certus® 140 | Neuwave Medical, Inc. | 17 |
| Emprint | Covidien LP | 14 |
| Betters (Suzhou)Medical Co., Ltd. | Betters(Suzhou) Medical Co., Ltd. | 11 |
| Emprint SX | Covidien LP | 11 |
| Mima-Pro | Mima-PRO (NAN Tong) Scientific Inc. | 10 |
| Dophi | Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. | 9 |
| Evident | Covidien LP | 8 |
Showing 12 of 55. All products under System, Ablation, Microwave And Accessories
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.