FACEGYM Pro Device (HD-109)— 510(k) K253932
Substantially EquivalentShenzhen Kaiyan Medical Equipment Co., Ltd.
FDA 510(k) clearance K253932 for FACEGYM Pro Device (HD-109), Substantially Equivalent on 2026-07-23. Applicant: Shenzhen Kaiyan Medical Equipment Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Shenzhen Kaiyan Medical Equipment Co., Ltd.
- Product code
- Code NFO
- Device class
- Class 2
- Regulation
- 21 CFR 882.5890
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Shenzhen, CN
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Data sourced from openFDA. This site is unofficial and independent of the FDA.