FDA 510(k)

经皮神经电刺激器（型号RJTENS-1）

K号: K220578 · 2022-05-25

申请人Bozhou Rongjian Medical Appliance Co., Ltd.

决定日期2022-05-25

产品代码GZJ

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

Transcutaneous Electrical Nerve Stimulator (Model RJTENS-1) is the device name listed in this FDA 510(k) record. The listed applicant is Bozhou Rongjian Medical Appliance Co., Ltd.. It received FDA 510(k) clearance on 2022-05-25 under 510(k) number K220578. The device is classified under product code GZJ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Transcutaneous Electrical Nerve Stimulator (Model RJTENS-1)?

Transcutaneous Electrical Nerve Stimulator (Model RJTENS-1) is a medical device that received FDA 510(k) clearance on 2022-05-25. The listed applicant is Bozhou Rongjian Medical Appliance Co., Ltd.. The 510(k) number is K220578.

When did Transcutaneous Electrical Nerve Stimulator (Model RJTENS-1) receive FDA 510(k) clearance?

Transcutaneous Electrical Nerve Stimulator (Model RJTENS-1) received FDA 510(k) clearance on 2022-05-25, under 510(k) number K220578.

Who is the listed applicant for Transcutaneous Electrical Nerve Stimulator (Model RJTENS-1)?

The FDA 510(k) record lists Bozhou Rongjian Medical Appliance Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Transcutaneous Electrical Nerve Stimulator (Model RJTENS-1)?

The FDA product code for Transcutaneous Electrical Nerve Stimulator (Model RJTENS-1) is GZJ.

列明Bozhou Rongjian Medical Appliance 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。

K252688经皮神经电刺激器（RJTENS-2）K220153针刺激器（型号：RJNS6-1）K213879自粘电极

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。