Patch-TEA (Model TRI-21)— 510(k) K243613

Substantially Equivalent

Transtimulation Research, Inc.

FDA 510(k) clearance K243613 for Patch-TEA (Model TRI-21), Substantially Equivalent on 2025-04-09. Applicant: Transtimulation Research, Inc.. Device class: 2.

Clearance details

Applicant
Transtimulation Research, Inc.
Product code
Code NUH
Device class
Class 2
Regulation
21 CFR 882.5890
Advisory panel
Neurology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Oklahoma City, OK, US
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