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FDA 510(k)

GEMORE TRUE SINE INTERFERENTIAL STIMULATOR

K-Number: K122944 · 2012-12-21

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

Device Summary

GEMORE TRUE SINE INTERFERENTIAL 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 K122944. The device is classified under product code LIH. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GEMORE TRUE SINE INTERFERENTIAL STIMULATOR?

GEMORE TRUE SINE INTERFERENTIAL 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 K122944.

When did GEMORE TRUE SINE INTERFERENTIAL STIMULATOR receive FDA 510(k) clearance?

GEMORE TRUE SINE INTERFERENTIAL STIMULATOR received FDA 510(k) clearance on 2012-12-21, under 510(k) number K122944.

Who is the listed applicant for GEMORE TRUE SINE INTERFERENTIAL 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 GEMORE TRUE SINE INTERFERENTIAL STIMULATOR?

The FDA product code for GEMORE TRUE SINE INTERFERENTIAL STIMULATOR is LIH.

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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 SystemK122948GEM-STIM COMBO 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: LIH)

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.

K231575Vecttor VT-300Artaflex, Inc.K202725ETD4000Therasigma, LLCK183692Avid IF2Vision Quest Industries Inc./Dba VQ OrthocareK121662VECTTOR VT-200Alan Neuromedical Technologies, LLCK110509EVERYWAY INTERFERNTIAL STIMULATOR, MODEL IF-908Everyway Medical Instruments Co.,LtdK100246MAX-IF1000Bio Protech, Inc.

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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