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FDA 510(k)

Electrical Stimulator System

K-Number: K192201 · 2020-06-12

Decision Date2020-06-12
Product CodeNUH
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Electrical Stimulator System is a medical device manufactured by Gymmax Technology Shenzen Co., Ltd.. It received FDA 510(k) clearance on 2020-06-12 under approval number K192201. 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 Electrical Stimulator System?

Electrical Stimulator System is a medical device that received FDA 510(k) clearance on 2020-06-12. It is manufactured by Gymmax Technology Shenzen Co., Ltd.. The 510(k) number is K192201.

When was Electrical Stimulator System approved by the FDA?

Electrical Stimulator System received FDA 510(k) clearance on 2020-06-12, under approval number K192201.

What company makes Electrical Stimulator System?

Electrical Stimulator System is manufactured by Gymmax Technology Shenzen Co., Ltd..

What is the FDA product code for Electrical Stimulator System?

The FDA product code for Electrical Stimulator System is NUH.

Related Clinical Trials

Other Devices by Gymmax Technology Shenzen Co., Ltd.

Related Devices (Code: NUH)

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.