FDA 510(k)

GEM-TWIN TENS/ MODELS GM3XY/Z

K-Number: K042559 · 2004-11-17

Decision Date2004-11-17

Product CodeGZJ

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

GEM-TWIN TENS/ MODELS GM3XY/Z 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 2004-11-17 under 510(k) number K042559. 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-TWIN TENS/ MODELS GM3XY/Z?

GEM-TWIN TENS/ MODELS GM3XY/Z is a medical device that received FDA 510(k) clearance on 2004-11-17. The listed applicant is Gemore Technology Co, Ltd.. The 510(k) number is K042559.

When did GEM-TWIN TENS/ MODELS GM3XY/Z receive FDA 510(k) clearance?

GEM-TWIN TENS/ MODELS GM3XY/Z received FDA 510(k) clearance on 2004-11-17, under 510(k) number K042559.

Who is the listed applicant for GEM-TWIN TENS/ MODELS GM3XY/Z?

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-TWIN TENS/ MODELS GM3XY/Z?

The FDA product code for GEM-TWIN TENS/ MODELS GM3XY/Z is GZJ.

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Other records listing Gemore Technology Co, Ltd. as applicant

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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.