FDA 510(k)

经皮神经电刺激/电肌肉刺激器（FT-247系列）（FT-247, FT-237）

K号: K260425 · 2026-06-16

决定日期2026-06-16

产品代码NUH

咨询委员会NE 请注意，您提供的文本“NE”不足以进行翻译，因为它不是一个完整的句子或描述。请提供完整的医疗设备监管文本，以便我能够进行准确的翻译。

决定实质等同

器械摘要

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.

常见问题

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.

列明Hivox Biotek, Inc.为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K242815POCKET TENS (EP-300)K232675加热经皮神经电刺激器，FT-615 K223308HEATING TENS/EMS, FT-810R K221384加热经皮神经电刺激/电肌肉刺激设备，FT-240-1，加热经皮神经电刺激/电肌肉刺激设备，FT-240-2 K211403HIVOX OTC 电刺激器，FT610-B K203574HIVOX OTC 电刺激器，EM59-l，HIVOX OTC 电刺激器，EM59-2

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相关器械（代码：NUH）

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K261131电肌肉刺激器（AST-105DJ，AST-105EJ，AST-105BJ，AST-105GJ，AST-303J，AST-309J，AST-310J；AST-300Q，AST-300Q-A，AST-500B；AST-500G，AST-500F；AST-500N；AST-500C，AST-500K，AST-500A；AST-300E，AST-500M，AST-500U，AST-500D；AST-500E。）Shenzhen Osto Medical Technology Co.,Ltd K260412TENS 7000 充电式 4通道（TENS 7000H）Shenzhen Dongdixin Technology Co., Ltd.K253896经皮神经电刺激（TENS）/电肌肉刺激器（GUSE01）Globalcare Medical Technology Co., Ltd.K253305经皮神经电刺激与电肌肉刺激（经皮神经电刺激和肌肉刺激器）（JT1065, JT1080, JT2080, JT9034）Shenzhen Jiantuo Electronics Co., Ltd.K253740经皮神经电刺激（TENS）和电肌肉刺激（HZ9151B, HZ9151C, HZ9151D）Hong Qiangxing (Shenzhen) Electronics Limited K251958VEINOPLUS 后置Dynapulse Medical

官方来源

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