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FDA 510(k)

PowerDot PD-01MT2 Muscle Stimulator

K-Number: K210938 · 2021-07-30

ApplicantSmartmissimo Technologies Pte, Ltd.
Decision Date2021-07-30
Product CodeIPF
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

PowerDot PD-01MT2 Muscle Stimulator is a medical device manufactured by Smartmissimo Technologies Pte, Ltd.. It received FDA 510(k) clearance on 2021-07-30 under approval number K210938. The device is classified under product code IPF. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PowerDot PD-01MT2 Muscle Stimulator?

PowerDot PD-01MT2 Muscle Stimulator is a medical device that received FDA 510(k) clearance on 2021-07-30. It is manufactured by Smartmissimo Technologies Pte, Ltd.. The 510(k) number is K210938.

When was PowerDot PD-01MT2 Muscle Stimulator approved by the FDA?

PowerDot PD-01MT2 Muscle Stimulator received FDA 510(k) clearance on 2021-07-30, under approval number K210938.

What company makes PowerDot PD-01MT2 Muscle Stimulator?

PowerDot PD-01MT2 Muscle Stimulator is manufactured by Smartmissimo Technologies Pte, Ltd..

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

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

Related Clinical Trials

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Other Devices by Smartmissimo Technologies Pte, Ltd.

K172876PowerDot PD-01M K181759PowerDot PD-01MT K210269PowerDot PD-01MT2 Muscle Stimulator

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Official Source

View on FDA Database →

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

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