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FDA 510(k)

Zionic Pro Max (EMS)

K-Number: K253636 · 2026-03-12

ApplicantTermosalud S.L.
Decision Date2026-03-12
Product CodeNGX
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

Zionic Pro Max (EMS) is a medical device manufactured by Termosalud S.L.. It received FDA 510(k) clearance on 2026-03-12 under approval number K253636. The device is classified under product code NGX. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Zionic Pro Max (EMS)?

Zionic Pro Max (EMS) is a medical device that received FDA 510(k) clearance on 2026-03-12. It is manufactured by Termosalud S.L.. The 510(k) number is K253636.

When was Zionic Pro Max (EMS) approved by the FDA?

Zionic Pro Max (EMS) received FDA 510(k) clearance on 2026-03-12, under approval number K253636.

What company makes Zionic Pro Max (EMS)?

Zionic Pro Max (EMS) is manufactured by Termosalud S.L..

What is the FDA product code for Zionic Pro Max (EMS)?

The FDA product code for Zionic Pro Max (EMS) is NGX.

Other Devices by Termosalud S.L.

K243716Zionic Pro Max (Radiofrequency)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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