Satelec
General surgery ultrasonic control console
6manufacturers in China registered for this device type
1catalogue number
1510(k) clearance
Who Else Makes It
Concentrated in Guangdong (3), Beijing (2), Shanghai (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Touchbeauty Beauty & Health (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 17 |
| Shenzhen Perfect Idea Technology Limited | Shenzhen | Guangdong | Contract manufacturer | 10 |
| Smtp Medical Co., Ltd. | Daxing District | Beijing | Manufacturer | 2 |
| Huaan Hengyi (Beijing) Medical Technology Co., Ltd. | Beijing | Beijing | Contract manufacturer | 2 |
| Shenzhen Codyson Electrical Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 2 |
Record
| Listed by | Satelec, United States |
|---|---|
| FDA product code | JDX |
| Device type | Instrument, Surgical, Sonic And Accessory/Attachment |
| Device class | Class 2 |
| Regulation | 21 CFR 888.4580 |
| Premarket notification | Exempt |
| Record published | 2022-07-13 |
| Record revised | 2024-04-16 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | manufacturing date, serial number |
| Storage | Storage environment temperature 0 to 50 °C; Storage environment humidity 10 to 100 % RH; Storage environment atmospheric pressure 50 to 106 KiloPascal |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| PIEZOTOME SOLO M+ US | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Acteon | Satelec | 95 |
| Tors | Radley Scientific Ltd | 76 |
| Smtp | Smtp Medical Co., Ltd. | 48 |
| Oscar PRO | Orthofix SRL | 36 |
| Ultra-Drive® Tool | Biomet Orthopedics | 11 |
| Mectron | Mectron SPA | 11 |
| Oscar | Orthosonics, Ltd. | 2 |
| Ultra-Drive® | Biomet Orthopedics | 1 |
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K100410 | 2010-04-28 |
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.