FDA 510(k)

组合电疗设备

K号: K231440 · 2023-11-03

申请人Shenzhen Roundwhale Technology Co. , Ltd.

决定日期2023-11-03

产品代码IPF

咨询委员会PM 请注意，由于您没有提供具体的医疗设备监管文本，我无法进行翻译。请提供具体的文本内容，以便我能够按照您的要求进行翻译。

决定实质等同

器械摘要

Combo Electrotherapy Device is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Roundwhale Technology Co. , Ltd.. It received FDA 510(k) clearance on 2023-11-03 under 510(k) number K231440. The device is classified under product code IPF. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Combo Electrotherapy Device?

Combo Electrotherapy Device is a medical device that received FDA 510(k) clearance on 2023-11-03. The listed applicant is Shenzhen Roundwhale Technology Co. , Ltd.. The 510(k) number is K231440.

When did Combo Electrotherapy Device receive FDA 510(k) clearance?

Combo Electrotherapy Device received FDA 510(k) clearance on 2023-11-03, under 510(k) number K231440.

Who is the listed applicant for Combo Electrotherapy Device?

The FDA 510(k) record lists Shenzhen Roundwhale Technology Co. , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Combo Electrotherapy Device?

The FDA product code for Combo Electrotherapy Device is IPF.

列明Shenzhen Roundwhale Technology Co. , Ltd.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。

K231423组合电疗设备（型号：R-C101C, R-C101D, R-C101F, R-C101G, F100, MINI-TENS-COMB, RC101I, TENS3500）K232995神经治疗设备 - 配件：腹部肌肉训练器紧致电极带，AC1001，AC1002，AC1003，AC1003，AC1004，AC1005；身体后部电极带，AC2001，AC2002，AC2003，AC2004；身体关节电极带，AC3001，AC3008，AC3009，AC3010，AC3011；膝关节电极，AC3002，AC3004，AC3006；肘关节电极，AC3003，AC3005，AC3007；电疗设备……K222252自粘电极 K192087组合电疗设备 K181688R-C1 TENS 和 EMS 刺激器；R-E1- EMS 刺激器；R-T1 TENS 刺激器 K180956电刺激器 - 模型R-C1 TENS和EMS刺激器，模型R-E1 EMS刺激器，模型R-T1 TENS刺激器

查看所有 7 个设备 →

官方来源

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