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FDA 510(k)

Tenex Health TX System

K-Number: K153299 · 2016-03-03

ApplicantTenex Health, Inc.
Decision Date2016-03-03
Product CodeLFL
DecisionSubstantially Equivalent

Device Summary

Tenex Health TX System is a medical device manufactured by Tenex Health, Inc.. It received FDA 510(k) clearance on 2016-03-03 under approval number K153299. The device is classified under product code LFL. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Tenex Health TX System?

Tenex Health TX System is a medical device that received FDA 510(k) clearance on 2016-03-03. It is manufactured by Tenex Health, Inc.. The 510(k) number is K153299.

When was Tenex Health TX System approved by the FDA?

Tenex Health TX System received FDA 510(k) clearance on 2016-03-03, under approval number K153299.

What company makes Tenex Health TX System?

Tenex Health TX System is manufactured by Tenex Health, Inc..

What is the FDA product code for Tenex Health TX System?

The FDA product code for Tenex Health TX System is LFL.

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Related PubMed Literature

PMID: 41887630 Capacity building for ethical use of artificial intelligence in health: protocol for a scoping review of training initiatives and gaps in Africa. BMJ open (2026) PMID: 41879133 Medical Device Regulation - Who Does the FDA Serve? The Journal of law, medicine & ethics : a journal of the American Society of Law, Medicine & Ethics (2026) PMID: 41734979 Strategies to Increase Patients' Adherence to Digital Therapeutics for Musculoskeletal Diseases: A Narrative Review. Yonsei medical journal (2026) PMID: 41608759 Collaborative and Cooperative Hospital "In-House" Medical Device Development and Implementation in the AI Age: The European Responsible AI Development (EURAID) Framework Compatible With European Values. Journal of medical Internet research (2026)

Other Devices by Tenex Health, Inc.

K181367Tenex Health TX System with the TXP MicroTip

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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.

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