K260948
- 510(k) number
- K260948
- Device name
- Air Compression Massager (EP30B001 I)
- Applicant
- Wavepulse (Xiamen) Healthcare Technology Co., Ltd. CN
- Product code
- IRP — Massager, Powered Inflatable Tube
- Decision date
- 2026-07-24
- Date received
- 2026-03-23
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Physical Medicine
PDFDownload 510(k) SummaryArchived here · 1.4 MB · U.S. public domain
Also available from FDA: K260948.pdf
Official FDA record: K260948
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.