Ulthera System Cart
Catalogue number UR-1 Rev. A, listed by Ulthera Inc, United States, under Table, Operating-Room, Non-Electrical. 3 manufacturers in China are registered for this product code.
3manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
All of them in Guangdong.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Foshan Zubon Technology Co., Ltd. | Foshan | Guangdong | Manufacturer | 23 |
| Foshan Suncare Medical Products Co Ltd | Foshan | Guangdong | Contract manufacturer | 20 |
| Foshan OST Medical Equipment Technology Co., Ltd. | Foshan | Guangdong | Contract manufacturer | 8 |
Record
| Listed by | Ulthera Inc, United States |
|---|---|
| FDA product code | FWY |
| Device type | Table, Operating-Room, Non-Electrical |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4950 |
| Establishment | Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2024-05-21 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| UR-1 Rev. A | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Ufsk-Osys Treatment table | Ufsk-International Osys Gmbh | 1 |
| Advanced Table, Operating-Room, NON-Electrical | Advanced Instrumentations, Inc. | 1 |
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.