Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Triathlon Pro

K-Number: K243131 · 2025-11-07

ApplicantSigma Biomedical
Decision Date2025-11-07
Product CodeNUH
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Triathlon Pro is the device name listed in this FDA 510(k) record. The listed applicant is Sigma Biomedical. It received FDA 510(k) clearance on 2025-11-07 under 510(k) number K243131. 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 Triathlon Pro?

Triathlon Pro is a medical device that received FDA 510(k) clearance on 2025-11-07. The listed applicant is Sigma Biomedical. The 510(k) number is K243131.

When did Triathlon Pro receive FDA 510(k) clearance?

Triathlon Pro received FDA 510(k) clearance on 2025-11-07, under 510(k) number K243131.

Who is the listed applicant for Triathlon Pro?

The FDA 510(k) record lists Sigma Biomedical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Triathlon Pro?

The FDA product code for Triathlon Pro is NUH.

Related Devices (Code: NUH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260412TENS 7000 Rechargeable 4 Channel (TENS 7000H)Shenzhen Dongdixin Technology Co., Ltd.K260425TENS / EMS DEVICE (FT-247 Series) (FT-247, FT-237)Hivox Biotek, Inc.K253896TENS/EMS device (GUSE01)Globalcare Medical Technology Co., Ltd.K253305TENS AND EMS (TENS and Muscle Stimulator) (JT1065, JT1080, JT2080, JT9034)Shenzhen Jiantuo Electronics Co., Ltd.K253740TENS&EMS (HZ9151B, HZ9151C, HZ9151D)Hong Qiangxing (Shenzhen) Electronics LimitedK251958VEINOPLUS BackDynapulse Medical

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.

↑