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FDA 510(k)

StimOnTM Pain Relief System (GM2439)

K-Number: K213802 · 2022-08-26

ApplicantGimer Medical Co., Ltd.
Decision Date2022-08-26
Product CodeGZJ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

StimOnTM Pain Relief System (GM2439) is a medical device manufactured by Gimer Medical Co., Ltd.. It received FDA 510(k) clearance on 2022-08-26 under approval number K213802. The device is classified under product code GZJ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the StimOnTM Pain Relief System (GM2439)?

StimOnTM Pain Relief System (GM2439) is a medical device that received FDA 510(k) clearance on 2022-08-26. It is manufactured by Gimer Medical Co., Ltd.. The 510(k) number is K213802.

When was StimOnTM Pain Relief System (GM2439) approved by the FDA?

StimOnTM Pain Relief System (GM2439) received FDA 510(k) clearance on 2022-08-26, under approval number K213802.

What company makes StimOnTM Pain Relief System (GM2439)?

StimOnTM Pain Relief System (GM2439) is manufactured by Gimer Medical Co., Ltd..

What is the FDA product code for StimOnTM Pain Relief System (GM2439)?

The FDA product code for StimOnTM Pain Relief System (GM2439) is GZJ.

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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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