FDA 510(k)

PowerDot PD-01MT2 肌肉刺激器

K号: K210269 · 2021-02-23

决定日期2021-02-23

产品代码IPF

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决定实质等同

器械摘要

PowerDot PD-01MT2 Muscle Stimulator is the device name listed in this FDA 510(k) record. The listed applicant is Smartmissimo Technologies Pte, Ltd.. It received FDA 510(k) clearance on 2021-02-23 under 510(k) number K210269. 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 PowerDot PD-01MT2 Muscle Stimulator?

PowerDot PD-01MT2 Muscle Stimulator is a medical device that received FDA 510(k) clearance on 2021-02-23. The listed applicant is Smartmissimo Technologies Pte, Ltd.. The 510(k) number is K210269.

When did PowerDot PD-01MT2 Muscle Stimulator receive FDA 510(k) clearance?

PowerDot PD-01MT2 Muscle Stimulator received FDA 510(k) clearance on 2021-02-23, under 510(k) number K210269.

Who is the listed applicant for PowerDot PD-01MT2 Muscle Stimulator?

The FDA 510(k) record lists Smartmissimo Technologies Pte, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PowerDot PD-01MT2 Muscle Stimulator?

The FDA product code for PowerDot PD-01MT2 Muscle Stimulator is IPF.

列明Smartmissimo Technologies Pte, 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。

K210938PowerDot PD-01MT2 肌肉刺激器 K181759PowerDot PD-01MT K172876PowerDot PD-01M

官方来源

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