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 a medical device manufactured by Cathay Manufacturing Corp.. It received FDA 510(k) clearance on 2016-10-19 under approval 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. It is manufactured by Cathay Manufacturing Corp.. The 510(k) number is K160081.
When was TENS Electrodes approved by the FDA?
TENS Electrodes received FDA 510(k) clearance on 2016-10-19, under approval number K160081.
What company makes TENS Electrodes?
TENS Electrodes is manufactured by Cathay Manufacturing Corp..
What is the FDA product code for TENS Electrodes?
The FDA product code for TENS Electrodes is GXY.
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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.