Patch-TEA (Model TRI-21)
K-Number: K243613 · 2025-04-09
ApplicantTranstimulation Research, Inc.
Decision Date2025-04-09
Product CodeNUH
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
Patch-TEA (Model TRI-21) is a medical device manufactured by Transtimulation Research, Inc.. It received FDA 510(k) clearance on 2025-04-09 under approval number K243613. 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 Patch-TEA (Model TRI-21)?
Patch-TEA (Model TRI-21) is a medical device that received FDA 510(k) clearance on 2025-04-09. It is manufactured by Transtimulation Research, Inc.. The 510(k) number is K243613.
When was Patch-TEA (Model TRI-21) approved by the FDA?
Patch-TEA (Model TRI-21) received FDA 510(k) clearance on 2025-04-09, under approval number K243613.
What company makes Patch-TEA (Model TRI-21)?
Patch-TEA (Model TRI-21) is manufactured by Transtimulation Research, Inc..
What is the FDA product code for Patch-TEA (Model TRI-21)?
The FDA product code for Patch-TEA (Model TRI-21) 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.