Oakworks Medical
Spine Positioning System II Large Torso - TT/EM
2manufacturers 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 |
|---|---|---|---|---|
| Guangdong Meicen Medical Equipment Co., Ltd. | Foshan | Guangdong | Manufacturer | 7 |
| Guangzhou Tian Hong Medical Technology Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 4 |
Record
| Listed by | Oakworks, Inc., United States |
|---|---|
| FDA product code | KXH |
| Device type | Cradle, Patient, Radiologic |
| Device class | Class 1 |
| Regulation | 21 CFR 892.1830 |
| Establishment | Manufacturer |
| Premarket notification | Exempt |
| Record published | 2016-10-12 |
| Record revised | 2025-12-19 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Over the counter | Yes |
| Label carries | manufacturing date, serial number |
| Distribution end date | 2024-12-31 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Spine Positioning System II | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| pearltec | Pearl Inc. | 27 |
| ProFoam | Pearl Inc. | 22 |
| Moldcare RI II | Alcare Co., Ltd. | 11 |
| Moldcare | IZI Medical Products LLC | 6 |
| AccuBoost | Advanced Radiation Therapy, LLC | 5 |
| PearlFit | Pearl Inc. | 3 |
| ProBelt | Pearl Inc. | 2 |
| ProFoam Wedge 18x23x10 30° | Pearl Inc. | 1 |
| ProBelt 50 VH | Pearl Inc. | 1 |
| PearlFit Inlay Head | Pearl Inc. | 1 |
| ProBelt 350 Wrap | Pearl Inc. | 1 |
| Small U Head Cushions | Octostop, Inc. | 1 |
Showing 12 of 137. All products under Cradle, Patient, Radiologic
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.