Medi-Direct TENS Pen
K-Number: K182671 · 2019-09-21
ApplicantJkh USA, LLC
Decision Date2019-09-21
Product CodeNUH
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
Medi-Direct TENS Pen is a medical device manufactured by Jkh USA, LLC. It received FDA 510(k) clearance on 2019-09-21 under approval number K182671. The device is classified under product code NUH. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Medi-Direct TENS Pen?
Medi-Direct TENS Pen is a medical device that received FDA 510(k) clearance on 2019-09-21. It is manufactured by Jkh USA, LLC. The 510(k) number is K182671.
When was Medi-Direct TENS Pen approved by the FDA?
Medi-Direct TENS Pen received FDA 510(k) clearance on 2019-09-21, under approval number K182671.
What company makes Medi-Direct TENS Pen?
Medi-Direct TENS Pen is manufactured by Jkh USA, LLC.
What is the FDA product code for Medi-Direct TENS Pen?
The FDA product code for Medi-Direct TENS Pen is NUH.
Other Devices by Jkh USA, LLC
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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.