FDA 510(k)

R-C1 TENS 和 EMS 刺激器；R-E1- EMS 刺激器；R-T1 TENS 刺激器

K号: K181688 · 2018-09-07

申请人Shenzhen Roundwhale Technology Co. , Ltd.

决定日期2018-09-07

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

R-C1 TENS and EMS Stimulator; R-E1- EMS Stimulator; R-T1 TENS Stimulator 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 2018-09-07 under 510(k) number K181688. 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 R-C1 TENS and EMS Stimulator; R-E1- EMS Stimulator; R-T1 TENS Stimulator?

R-C1 TENS and EMS Stimulator; R-E1- EMS Stimulator; R-T1 TENS Stimulator is a medical device that received FDA 510(k) clearance on 2018-09-07. The listed applicant is Shenzhen Roundwhale Technology Co. , Ltd.. The 510(k) number is K181688.

When did R-C1 TENS and EMS Stimulator; R-E1- EMS Stimulator; R-T1 TENS Stimulator receive FDA 510(k) clearance?

R-C1 TENS and EMS Stimulator; R-E1- EMS Stimulator; R-T1 TENS Stimulator received FDA 510(k) clearance on 2018-09-07, under 510(k) number K181688.

Who is the listed applicant for R-C1 TENS and EMS Stimulator; R-E1- EMS Stimulator; R-T1 TENS Stimulator?

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 R-C1 TENS and EMS Stimulator; R-E1- EMS Stimulator; R-T1 TENS Stimulator?

The FDA product code for R-C1 TENS and EMS Stimulator; R-E1- EMS Stimulator; R-T1 TENS Stimulator 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……K231440组合电疗设备 K222252自粘电极 K192087组合电疗设备 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

在 FDA 数据库中查看 →

数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。