FDA 510(k)

经皮神经电刺激器（型号：TENS WMPS6-1）

K号: K222879 · 2023-01-24

申请人Wuxi Jiajian Medical Instrument Co., Ltd.

决定日期2023-01-24

产品代码GZJ

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决定实质等同

器械摘要

Transcutaneous Electrical Nerve Stimulator (model: TENS WMPS6-1) is the device name listed in this FDA 510(k) record. The listed applicant is Wuxi Jiajian Medical Instrument Co., Ltd.. It received FDA 510(k) clearance on 2023-01-24 under 510(k) number K222879. 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: TENS WMPS6-1)?

Transcutaneous Electrical Nerve Stimulator (model: TENS WMPS6-1) is a medical device that received FDA 510(k) clearance on 2023-01-24. The listed applicant is Wuxi Jiajian Medical Instrument Co., Ltd.. The 510(k) number is K222879.

When did Transcutaneous Electrical Nerve Stimulator (model: TENS WMPS6-1) receive FDA 510(k) clearance?

Transcutaneous Electrical Nerve Stimulator (model: TENS WMPS6-1) received FDA 510(k) clearance on 2023-01-24, under 510(k) number K222879.

Who is the listed applicant for Transcutaneous Electrical Nerve Stimulator (model: TENS WMPS6-1)?

The FDA 510(k) record lists Wuxi Jiajian Medical Instrument 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: TENS WMPS6-1)?

The FDA product code for Transcutaneous Electrical Nerve Stimulator (model: TENS WMPS6-1) is GZJ.

列明Wuxi Jiajian Medical Instrument 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。

K244030针刺激器（CMNS6-1 PLUS, CMNS6-3）K231425经皮神经电刺激器（TENS WMPS2-1）K202861针刺激器 K202893经皮神经电刺激器 K192568嘉健自粘电极

官方来源

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