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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 the device name listed in this FDA 510(k) record. The listed applicant is Termosalud S.L.. It received FDA 510(k) clearance on 2026-03-12 under 510(k) 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. The listed applicant is Termosalud S.L.. The 510(k) number is K253636.

When did Zionic Pro Max (EMS) receive FDA 510(k) clearance?

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

Who is the listed applicant for Zionic Pro Max (EMS)?

The FDA 510(k) record lists Termosalud S.L. as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Termosalud S.L. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261473ChromixK243716Zionic Pro Max (Radiofrequency)

Related Devices (Code: NGX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253790High Intensity Focused Electromagnetic Stimulation Device (FE60)Beijing Winkonlaser Technology LimitedK253926DiacoreShenB Co., Ltd.K253408CoolToneZimmer Medizinsysteme GmbHK252154Portable Electro Stimulation Therapy Device (LGT-2320BE, LGT-2320ME, and LGT-2320SP)Guangzhou Longest Medical Technology Co., Ltd.K253478Motive™ Muscle Stimulator for Lower Back (OT01-1003)Motive Health, Inc.K251594truFlexSyrma Johari Medtech Limited

Official Source

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

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