FACEGYM Pro Device (HD-109)
Device Facts
| Record ID | K253932 |
|---|---|
| Device Name | FACEGYM Pro Device (HD-109) |
| Applicant | Shenzhen Kaiyan Medical Equipment Co., Ltd. |
| Product Code | NFO · Neurology |
| Decision Date | Jul 23, 2026 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 882.5890 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.
