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FDA 510(k)

GM3 SERIES HV TENS, MODEL GM3X3HV (WHERE X IS PARAMETER OF DIFFERENT HOUSING)

K-Number: K032994 · 2003-12-16

ApplicantGemore Technology Co, Ltd.
Decision Date2003-12-16
Product CodeGZJ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

GM3 SERIES HV TENS, MODEL GM3X3HV (WHERE X IS PARAMETER OF DIFFERENT HOUSING) 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 2003-12-16 under 510(k) number K032994. 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 GM3 SERIES HV TENS, MODEL GM3X3HV (WHERE X IS PARAMETER OF DIFFERENT HOUSING)?

GM3 SERIES HV TENS, MODEL GM3X3HV (WHERE X IS PARAMETER OF DIFFERENT HOUSING) is a medical device that received FDA 510(k) clearance on 2003-12-16. The listed applicant is Gemore Technology Co, Ltd.. The 510(k) number is K032994.

When did GM3 SERIES HV TENS, MODEL GM3X3HV (WHERE X IS PARAMETER OF DIFFERENT HOUSING) receive FDA 510(k) clearance?

GM3 SERIES HV TENS, MODEL GM3X3HV (WHERE X IS PARAMETER OF DIFFERENT HOUSING) received FDA 510(k) clearance on 2003-12-16, under 510(k) number K032994.

Who is the listed applicant for GM3 SERIES HV TENS, MODEL GM3X3HV (WHERE X IS PARAMETER OF DIFFERENT HOUSING)?

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 GM3 SERIES HV TENS, MODEL GM3X3HV (WHERE X IS PARAMETER OF DIFFERENT HOUSING)?

The FDA product code for GM3 SERIES HV TENS, MODEL GM3X3HV (WHERE X IS PARAMETER OF DIFFERENT HOUSING) is GZJ.

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Other records listing Gemore Technology Co, Ltd. as applicant

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.

K190988GIM-STIM OTC TENS/EMS SystemK122944GEMORE TRUE SINE INTERFERENTIAL STIMULATORK122948GEM-STIM COMBO STIMULATORK120569GEMORE TENS SYSTEMK102933GEM-TONE BODY TRAINING SYSTEMK102926GEMORE MUSCLE CONDITIONER;

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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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