K242754
- 510(k) number
- K242754
- Device name
- ZT Clinic (MG675A); ZT Cube (ZC3) (MG465A); Z-ONE (MG455A)
- Applicant
- Zamar Medical D.O.O. HR
- Product code
- IRP — Massager, Powered Inflatable Tube
- Decision date
- 2025-05-05
- Date received
- 2024-09-12
- 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: K242754.pdf
Official FDA record: K242754
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.