FDA 510(k)

Everyway失禁刺激系统

K号: K213116 · 2021-12-03

决定日期2021-12-03

产品代码KPI

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决定实质等同

器械摘要

Everyway Incontinence Stimulation System is the device name listed in this FDA 510(k) record. The listed applicant is Everyway Medical Instruments Co.,Ltd. It received FDA 510(k) clearance on 2021-12-03 under 510(k) number K213116. The device is classified under product code KPI. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Everyway Incontinence Stimulation System?

Everyway Incontinence Stimulation System is a medical device that received FDA 510(k) clearance on 2021-12-03. The listed applicant is Everyway Medical Instruments Co.,Ltd. The 510(k) number is K213116.

When did Everyway Incontinence Stimulation System receive FDA 510(k) clearance?

Everyway Incontinence Stimulation System received FDA 510(k) clearance on 2021-12-03, under 510(k) number K213116.

Who is the listed applicant for Everyway Incontinence Stimulation System?

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

What is the FDA product code for Everyway Incontinence Stimulation System?

The FDA product code for Everyway Incontinence Stimulation System is KPI.

列明Everyway Medical Instruments 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。

K251856锂电池供电OTC TENS/EMS组合刺激器，型号Z4 K222488Everyway模拟OTC经皮神经电刺激（TENS）K202849Everyway模拟OTC经皮神经电刺激（TENS），型号N103A/N302 K202470锂电池供电OTC TENS/EMS，型号EM-6000，EM-6100，EM-6200 & EM-6300 K202317锂电池供电OTC TENS/EMS，型号EV-804，型号EV-805，&型号EV-806 K201335锂电池供电OTC TENS/EMS组合刺激器

查看所有 13 个设备 →

相关器械（代码：KPI）

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。

K262353BTL-299-FBTL Industries, Inc.K260178盆底肌肉训练器（KM510，KM516B）Shenzhen Konmed Technology Co., Ltd.K252601盆底肌肉训练器（PC22A）；盆底肌肉训练器（PC22A-L）；盆底肌肉训练器（PC22E）；盆底肌肉训练器（PC22E-L）Hunan Accurate Bio-Medical Technology Co., Ltd.K252552Pelvic Floor Rehabilitation Therapy Device (PD2301/PD2302/PD2303)Shenzhen Changkun Technology Co., Ltd.K252831Pelvic Floor Treatment Device (DLR-8920, DLR-8921, DLR-8922, DLR-8923, DLR-8924, DLR-8925, DLR-8926, DLR-8927)Dolanvy (Suzhou) Medical Technology Co., Ltd.K252334PELVIPOWER盆腔功能性磁刺激(PELVIPOWER盆腔FMS)(033-0-1100-02)Pontemedag

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