FDA 510(k)

GEM-STIM TENS, MODELS GM3XY AND GM3AXY

K-Number: K032720 · 2003-12-10

Decision Date2003-12-10

Product CodeGZJ

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

GEM-STIM TENS, MODELS GM3XY AND GM3AXY 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 2003-12-10 under 510(k) number K032720. 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 TENS, MODELS GM3XY AND GM3AXY?

GEM-STIM TENS, MODELS GM3XY AND GM3AXY is a medical device that received FDA 510(k) clearance on 2003-12-10. The listed applicant is Gemore Technology Co, Ltd.. The 510(k) number is K032720.

When did GEM-STIM TENS, MODELS GM3XY AND GM3AXY receive FDA 510(k) clearance?

GEM-STIM TENS, MODELS GM3XY AND GM3AXY received FDA 510(k) clearance on 2003-12-10, under 510(k) number K032720.

Who is the listed applicant for GEM-STIM TENS, MODELS GM3XY AND GM3AXY?

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 TENS, MODELS GM3XY AND GM3AXY?

The FDA product code for GEM-STIM TENS, MODELS GM3XY AND GM3AXY is GZJ.

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Other records listing Gemore Technology Co, Ltd. as applicant

K190988GIM-STIM OTC TENS/EMS System K122944GEMORE TRUE SINE INTERFERENTIAL STIMULATOR K122948GEM-STIM COMBO STIMULATOR K120569GEMORE TENS SYSTEM K102933GEM-TONE BODY TRAINING SYSTEM K102926GEMORE MUSCLE CONDITIONER;

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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.