FDA 510(k)

PowerDot PD-01M

K-Number: K172876 · 2017-12-04

ApplicantSmartmissimo Technologies Pte, Ltd.

Decision Date2017-12-04

Product CodeNGX

Advisory CommitteePM

DecisionSubstantially Equivalent

Device Summary

PowerDot PD-01M is a medical device manufactured by Smartmissimo Technologies Pte, Ltd.. It received FDA 510(k) clearance on 2017-12-04 under approval number K172876. The device is classified under product code NGX. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PowerDot PD-01M?

PowerDot PD-01M is a medical device that received FDA 510(k) clearance on 2017-12-04. It is manufactured by Smartmissimo Technologies Pte, Ltd.. The 510(k) number is K172876.

When was PowerDot PD-01M approved by the FDA?

PowerDot PD-01M received FDA 510(k) clearance on 2017-12-04, under approval number K172876.

What company makes PowerDot PD-01M?

PowerDot PD-01M is manufactured by Smartmissimo Technologies Pte, Ltd..

What is the FDA product code for PowerDot PD-01M?

The FDA product code for PowerDot PD-01M is NGX.

Other Devices by Smartmissimo Technologies Pte, Ltd.

K181759PowerDot PD-01MT K210938PowerDot PD-01MT2 Muscle Stimulator K210269PowerDot PD-01MT2 Muscle Stimulator

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.