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FDA 510(k)

GIM-STIM OTC TENS/EMS System

K-Number: K190988 · 2019-08-16

ApplicantGemore Technology Co, Ltd.
Decision Date2019-08-16
Product CodeNUH
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

GIM-STIM OTC TENS/EMS System is the device name listed in this FDA 510(k) record. The listed applicant is Gemore Technology Co, Ltd.. It received FDA 510(k) clearance on 2019-08-16 under 510(k) 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. The listed applicant is Gemore Technology Co, Ltd.. The 510(k) number is K190988.

When did GIM-STIM OTC TENS/EMS System receive FDA 510(k) clearance?

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

Who is the listed applicant for GIM-STIM OTC TENS/EMS System?

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

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)

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.

K260412TENS 7000 Rechargeable 4 Channel (TENS 7000H)Shenzhen Dongdixin Technology Co., Ltd.K260425TENS / EMS DEVICE (FT-247 Series) (FT-247, FT-237)Hivox Biotek, Inc.K253896TENS/EMS device (GUSE01)Globalcare Medical Technology Co., Ltd.K253305TENS AND EMS (TENS and Muscle Stimulator) (JT1065, JT1080, JT2080, JT9034)Shenzhen Jiantuo Electronics Co., Ltd.K253740TENS&EMS (HZ9151B, HZ9151C, HZ9151D)Hong Qiangxing (Shenzhen) Electronics LimitedK251958VEINOPLUS BackDynapulse Medical

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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