Zionic Pro Max (EMS)— 510(k) K253636
Substantially EquivalentTermosalud S.L.
FDA 510(k) clearance K253636 for Zionic Pro Max (EMS), Substantially Equivalent on 2026-03-12. Applicant: Termosalud S.L.. Device class: 2.
Summary
Termosalud's Zionic Pro Max (EMS) is filed under NGX, powered muscle stimulators for muscle conditioning. The record doesn't describe the device beyond its name and that code name.
Class II, 21 CFR 890.5850. Physical Medicine is both the classification panel and the review panel, and it came in as a Traditional 510(k).
Termosalud filed from Gijon, Spain. Review took 113 calendar days (November 19, 2025 to March 12, 2026).
Clearance details
- Applicant
- Termosalud S.L.
- Product code
- Product code NGX
- Device class
- Class 2
- Regulation
- 21 CFR 890.5850
- Advisory panel
- Physical Medicine
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Gijon, ES
Recent devices under product code NGX
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