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FDA 510(k)

PlayMakar Sport Muscle Stimulator, Model PRO-500

K-Number: K182581 · 2018-11-21

ApplicantPlaymakar, Inc.
Decision Date2018-11-21
Product CodeNUH
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

PlayMakar Sport Muscle Stimulator, Model PRO-500 is a medical device manufactured by Playmakar, Inc.. It received FDA 510(k) clearance on 2018-11-21 under approval number K182581. The device is classified under product code NUH. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PlayMakar Sport Muscle Stimulator, Model PRO-500?

PlayMakar Sport Muscle Stimulator, Model PRO-500 is a medical device that received FDA 510(k) clearance on 2018-11-21. It is manufactured by Playmakar, Inc.. The 510(k) number is K182581.

When was PlayMakar Sport Muscle Stimulator, Model PRO-500 approved by the FDA?

PlayMakar Sport Muscle Stimulator, Model PRO-500 received FDA 510(k) clearance on 2018-11-21, under approval number K182581.

What company makes PlayMakar Sport Muscle Stimulator, Model PRO-500?

PlayMakar Sport Muscle Stimulator, Model PRO-500 is manufactured by Playmakar, Inc..

What is the FDA product code for PlayMakar Sport Muscle Stimulator, Model PRO-500?

The FDA product code for PlayMakar Sport Muscle Stimulator, Model PRO-500 is NUH.

Related Clinical Trials

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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.

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