FDA 510(k)

GIM-STIM OTC TENS/EMS System

K-Number: K190988 · 2019-08-16

Decision Date2019-08-16

Product CodeNUH

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

GIM-STIM OTC TENS/EMS System is a medical device manufactured by Gemore Technology Co, Ltd.. It received FDA 510(k) clearance on 2019-08-16 under approval number K190988. 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 GIM-STIM OTC TENS/EMS System?

GIM-STIM OTC TENS/EMS System is a medical device that received FDA 510(k) clearance on 2019-08-16. It is manufactured by Gemore Technology Co, Ltd.. The 510(k) number is K190988.

When was GIM-STIM OTC TENS/EMS System approved by the FDA?

GIM-STIM OTC TENS/EMS System received FDA 510(k) clearance on 2019-08-16, under approval number K190988.

What company makes GIM-STIM OTC TENS/EMS System?

GIM-STIM OTC TENS/EMS System is manufactured by Gemore Technology Co, Ltd..

What is the FDA product code for GIM-STIM OTC TENS/EMS System?

The FDA product code for GIM-STIM OTC TENS/EMS System is NUH.

Related Devices (Code: NUH)

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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.