K251622
- 510(k) number
- K251622
- Device name
- Hand Massager (SM004D)
- Applicant
- Ningbo Zhenhai Yihao Electronic Technology Co., Ltd. CN
- Product code
- IRP — Massager, Powered Inflatable Tube
- Decision date
- 2026-01-28
- Date received
- 2025-05-28
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Physical Medicine
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K251622.pdf
Official FDA record: K251622
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.