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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 the device name listed in this FDA 510(k) record. The listed applicant is Gimer Medical Co., Ltd.. It received FDA 510(k) clearance on 2022-08-26 under 510(k) 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. The listed applicant is Gimer Medical Co., Ltd.. The 510(k) number is K213802.

When did StimOnTM Pain Relief System (GM2439) receive FDA 510(k) clearance?

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

Who is the listed applicant for StimOnTM Pain Relief System (GM2439)?

The FDA 510(k) record lists Gimer Medical Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

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

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

Related Devices (Code: GZJ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252712STIMPOD NMS460 Nerve StimulatorAlgiamed Technologies USA, Inc.K252767actiTENS miniSublimedK252236CP Relief Wand Rx - TENS/NMESN & C Holdings, LLCK232441Unipro (K-UNIPRO-US)Tenscare, Ltd.K241228TENSWaveZynex Medical OfficerK233046Electrical Neuromuscular Stimulator, Cure TrioOriental Inspiration Limited

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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