Cleared Traditional

Triathlon Pro

K243131 · Sigma Biomedical · Neurology

Nov 2025

Decision

403d

Days

Class 2

Risk

About This 510(k) Submission

K243131 is an FDA 510(k) clearance for the Triathlon Pro, a Stimulator, Nerve, Transcutaneous, Over-the-counter (Class II — Special Controls, product code NUH), submitted by Sigma Biomedical (Sunrise, US). The FDA issued a Cleared decision on November 7, 2025, 403 days after receiving the submission on September 30, 2024. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5890.

Submission Details

510(k) Number	K243131 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 30, 2024
Decision Date	November 07, 2025
Days to Decision	403 days
Submission Type	Traditional
Review Panel	Neurology (NE)
Summary	Summary PDF

Device Classification

Product Code	NUH — Stimulator, Nerve, Transcutaneous, Over-the-counter
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 882.5890
Definition	Temporary Relief Of Pain Due To Sore/aching Muscles