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FDA 510(k)

GEM-STIM COMBO STIMULATOR

K-Number: K122948 · 2012-12-21

ApplicantGemore Technology Co, Ltd.
Decision Date2012-12-21
Product CodeGZJ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

GEM-STIM COMBO STIMULATOR 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 2012-12-21 under 510(k) number K122948. 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 GEM-STIM COMBO STIMULATOR?

GEM-STIM COMBO STIMULATOR is a medical device that received FDA 510(k) clearance on 2012-12-21. The listed applicant is Gemore Technology Co, Ltd.. The 510(k) number is K122948.

When did GEM-STIM COMBO STIMULATOR receive FDA 510(k) clearance?

GEM-STIM COMBO STIMULATOR received FDA 510(k) clearance on 2012-12-21, under 510(k) number K122948.

Who is the listed applicant for GEM-STIM COMBO STIMULATOR?

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 GEM-STIM COMBO STIMULATOR?

The FDA product code for GEM-STIM COMBO STIMULATOR 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 STIMULATORK120569GEMORE TENS SYSTEMK102933GEM-TONE BODY TRAINING SYSTEMK102926GEMORE MUSCLE CONDITIONER;K091833GEM-STONE ABDOMINAL TRAINING SYSTEM; MODEL GEM-TONE 310PE/320PE/330PE/340PE/350PE.

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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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