K253636
- 510(k) number
- K253636
- Device name
- Zionic Pro Max (EMS)
- Applicant
- Termosalud S.L. ES
- Product code
- NGX — Stimulator, Muscle, Powered, For Muscle Conditioning
- Decision date
- 2026-03-12
- Date received
- 2025-11-19
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Physical Medicine
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K253636.pdf
Official FDA record: K253636
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.