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FDA 510(k)

TrainFES Advance

K-Number: K241488 · 2025-02-05

ApplicantTrainfes
Decision Date2025-02-05
Product CodeIPF
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

TrainFES Advance is the device name listed in this FDA 510(k) record. The listed applicant is Trainfes. It received FDA 510(k) clearance on 2025-02-05 under 510(k) number K241488. The device is classified under product code IPF. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TrainFES Advance?

TrainFES Advance is a medical device that received FDA 510(k) clearance on 2025-02-05. The listed applicant is Trainfes. The 510(k) number is K241488.

When did TrainFES Advance receive FDA 510(k) clearance?

TrainFES Advance received FDA 510(k) clearance on 2025-02-05, under 510(k) number K241488.

Who is the listed applicant for TrainFES Advance?

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

What is the FDA product code for TrainFES Advance?

The FDA product code for TrainFES Advance is IPF.

Related Devices (Code: IPF)

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.

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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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