FDA 510(k)

Zionic Pro Max (電動肌肉刺激器)

K 號：K253636 · 2026-03-12

決定日期2026-03-12

產品代碼NGX

諮詢委員會PM

決定相當於

器材摘要

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.

常見問題

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.

其他以 Termosalud S.L. 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K261473Chromix K243716Zionic Pro Max (電波頻率)

相關器械（代碼：NGX）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K253790高強度聚焦電磁刺激器（FE60）Beijing Winkonlaser Technology Limited K253926迪阿科爾ShenB Co., Ltd.K253408涼頻Zimmer Medizinsysteme GmbH K252154攜帶式電刺激治療設備（LGT-2320BE、LGT-2320ME 及 LGT-2320SP）Guangzhou Longest Medical Technology Co., Ltd.K253478Motive™ 腰部肌肉刺激器 (OT01-1003)Motive Health, Inc.K251594truFlexSyrma Johari Medtech Limited

官方來源

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