FDA 510(k)

Patch-TEA (Model TRI-21)

Número K: K243613 · 2025-04-09

RequerenteTranstimulation Research, Inc.

Data da decisão2025-04-09

Código do produtoNUH

Comité consultivoNE

DecisãoSubstantially Equivalent

Resumo do dispositivo

Patch-TEA (Model TRI-21) is the device name listed in this FDA 510(k) record. The listed applicant is Transtimulation Research, Inc.. It received FDA 510(k) clearance on 2025-04-09 under 510(k) number K243613. The device is classified under product code NUH. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

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. The listed applicant is Transtimulation Research, Inc.. The 510(k) number is K243613.

When did Patch-TEA (Model TRI-21) receive FDA 510(k) clearance?

Patch-TEA (Model TRI-21) received FDA 510(k) clearance on 2025-04-09, under 510(k) number K243613.

Who is the listed applicant for Patch-TEA (Model TRI-21)?

The FDA 510(k) record lists Transtimulation Research, Inc. as the applicant. This does not by itself establish the device manufacturer.

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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Fonte oficial

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