Data / Medical devices / High Intensity Focused Ultrasound System For Peripheral Neural Tissue Ablation
High Intensity Focused Ultrasound System For Peripheral Neural Tissue Ablation (SGN): 4 FDA-registered makers in 3 countries
4 establishments in 3 countries are registered with the FDA to make High Intensity Focused Ultrasound System For Peripheral Neural Tissue Ablation (product code SGN, Class 2, 21 CFR 882.4420). 1 of them has a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 1 510(k) clearance under this code, the latest on November 14, 2025, and lists 0 recall events (0 Class I). FDA data exported November 3, 2026.
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- Product code
- SGN
- Device class
- 2
- Regulation
- 882.4420
- Medical specialty
- Neurology
Makers by country
| Country | Makers |
|---|---|
| China | 2 |
| United States | 1 |
| Hong Kong | 1 |
Makers of High Intensity Focused Ultrasound System For Peripheral Neural Tissue Ablation
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Fusmobile, Inc | Alpharetta, GA, United States | Manufacturer | 1 | November 14, 2025 | 0 | 0 | 0 | api.fda.gov |
| Gorgeous Beauty Equipment Manufacture Limited | Hong Kong, Hong Kong | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hebei Lufen Tech Co., Limited | Xingtai Hebei, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hebei Tuosite Technology Co.,ltd | Shijiazhuang Hebei, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 14, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.