POCKET TENS (EP-300)
K-Number: K242815 · 2024-12-17
ApplicantHivox Biotek, Inc.
Decision Date2024-12-17
Product CodeNUH
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
POCKET TENS (EP-300) is a medical device manufactured by Hivox Biotek, Inc.. It received FDA 510(k) clearance on 2024-12-17 under approval number K242815. 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 POCKET TENS (EP-300)?
POCKET TENS (EP-300) is a medical device that received FDA 510(k) clearance on 2024-12-17. It is manufactured by Hivox Biotek, Inc.. The 510(k) number is K242815.
When was POCKET TENS (EP-300) approved by the FDA?
POCKET TENS (EP-300) received FDA 510(k) clearance on 2024-12-17, under approval number K242815.
What company makes POCKET TENS (EP-300)?
POCKET TENS (EP-300) is manufactured by Hivox Biotek, Inc..
What is the FDA product code for POCKET TENS (EP-300)?
The FDA product code for POCKET TENS (EP-300) is NUH.
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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.