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FDA 510(k)

TENS Electrodes

K-Number: K160081 · 2016-10-19

ApplicantCathay Manufacturing Corp.
Decision Date2016-10-19
Product CodeGXY
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

TENS Electrodes is the device name listed in this FDA 510(k) record. The listed applicant is Cathay Manufacturing Corp.. It received FDA 510(k) clearance on 2016-10-19 under 510(k) number K160081. The device is classified under product code GXY. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TENS Electrodes?

TENS Electrodes is a medical device that received FDA 510(k) clearance on 2016-10-19. The listed applicant is Cathay Manufacturing Corp.. The 510(k) number is K160081.

When did TENS Electrodes receive FDA 510(k) clearance?

TENS Electrodes received FDA 510(k) clearance on 2016-10-19, under 510(k) number K160081.

Who is the listed applicant for TENS Electrodes?

The FDA 510(k) record lists Cathay Manufacturing Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TENS Electrodes?

The FDA product code for TENS Electrodes is GXY.

Related Clinical Trials

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.

NCT07578324TENS as an Adjunct to Local Anaesthesia During Transperineal Prostate Biopsy: A Randomized Sham-Controlled TrialNOT_YET_RECRUITING

Related Devices (Code: GXY)

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.

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Official Source

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