Neurolyser XR DQA Assembly
Catalogue number 820-00008, listed by Fusmobile, Inc, United States, under High Intensity Focused Ultrasound System For Peripheral Neural Tissue Ablation. 2 manufacturers in China are registered for this product code.
2manufacturers in China registered for this device type
1catalogue number
1510(k) clearance
Who Else Makes It
All of them in Hebei.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hebei Tuosite Technology Co., Ltd. | Shijiazhuang | Hebei | Manufacturer | 14 |
| Hebei Lufen Tech Co., Limited | Xingtai | Hebei | Contract manufacturer | 12 |
Record
| Listed by | Fusmobile, Inc, United States |
|---|---|
| FDA product code | SGN |
| Device type | High Intensity Focused Ultrasound System For Peripheral Neural Tissue Ablation |
| Device class | Class 2 |
| Regulation | 21 CFR 882.4420 |
| Establishment | Manufacturer |
| 510(k) | DEN250015 |
| Record published | 2025-12-10 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
| Storage | Storage environment temperature -10 to 27 °C; Special storage condition: Don’t expose to sunlight |
| Packaging | Box |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 820-00008 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Neurolyser XR | Fusmobile, Inc | 1 |
| Neurolyser XR 30 mm Gel Pad | Fusmobile, Inc | 1 |
| Neurolyser XR 45 mm Gel Pad | Fusmobile, Inc | 1 |
510(K) Clearances
| Clearance | Decision date |
|---|---|
| DEN250015 | 2025-11-14 |
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.