510(k) K253932 ยท NFO Stimulator, Transcutaneous Electrical, Aesthetic Purposes
FACEGYM Pro Device (HD-109)
| Applicant | Shenzhen Kaiyan Medical Equipment Co., Ltd., Shenzhen, CN |
| Decision | Substantially Equivalent, Jul 23, 2026 |
| Received | Dec 9, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253932
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.