FDA 510(k)

TENS / EMS 裝置（FT-247 系列產品）（FT-247，FT-237）

K 號：K260425 · 2026-06-16

決定日期2026-06-16

產品代碼NUH

諮詢委員會NE (請提供完整的英文描述，以便進行翻譯。)

決定相當於

器材摘要

TENS / EMS DEVICE (FT-247 Series) (FT-247, FT-237) is the device name listed in this FDA 510(k) record. The listed applicant is Hivox Biotek, Inc.. It received FDA 510(k) clearance on 2026-06-16 under 510(k) number K260425. The device is classified under product code NUH. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the TENS / EMS DEVICE (FT-247 Series) (FT-247, FT-237)?

TENS / EMS DEVICE (FT-247 Series) (FT-247, FT-237) is a medical device that received FDA 510(k) clearance on 2026-06-16. The listed applicant is Hivox Biotek, Inc.. The 510(k) number is K260425.

When did TENS / EMS DEVICE (FT-247 Series) (FT-247, FT-237) receive FDA 510(k) clearance?

TENS / EMS DEVICE (FT-247 Series) (FT-247, FT-237) received FDA 510(k) clearance on 2026-06-16, under 510(k) number K260425.

Who is the listed applicant for TENS / EMS DEVICE (FT-247 Series) (FT-247, FT-237)?

The FDA 510(k) record lists Hivox Biotek, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TENS / EMS DEVICE (FT-247 Series) (FT-247, FT-237)?

The FDA product code for TENS / EMS DEVICE (FT-247 Series) (FT-247, FT-237) is NUH.

其他以 Hivox Biotek, Inc. 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。

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相關器械（代碼：NUH）

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。

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官方來源

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