FDA 510(k)

偏头痛数字经颅电刺激疼痛缓解器

K号: K210364 · 2021-06-17

申请人Shenzhen Dongdixin Technology Co., Ltd.

决定日期2021-06-17

产品代码PCC

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

Migraine Tens Digital Pain Reliever is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Dongdixin Technology Co., Ltd.. It received FDA 510(k) clearance on 2021-06-17 under 510(k) number K210364. The device is classified under product code PCC. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Migraine Tens Digital Pain Reliever?

Migraine Tens Digital Pain Reliever is a medical device that received FDA 510(k) clearance on 2021-06-17. The listed applicant is Shenzhen Dongdixin Technology Co., Ltd.. The 510(k) number is K210364.

When did Migraine Tens Digital Pain Reliever receive FDA 510(k) clearance?

Migraine Tens Digital Pain Reliever received FDA 510(k) clearance on 2021-06-17, under 510(k) number K210364.

Who is the listed applicant for Migraine Tens Digital Pain Reliever?

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

What is the FDA product code for Migraine Tens Digital Pain Reliever?

The FDA product code for Migraine Tens Digital Pain Reliever is PCC.

列明Shenzhen Dongdixin 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。

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官方来源

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