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FDA 510(k)

truFlex

K-Number: K251594 · 2025-08-28

ApplicantSyrma Johari Medtech Limited
Decision Date2025-08-28
Product CodeNGX
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

truFlex is a medical device manufactured by Syrma Johari Medtech Limited. It received FDA 510(k) clearance on 2025-08-28 under approval number K251594. The device is classified under product code NGX. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the truFlex?

truFlex is a medical device that received FDA 510(k) clearance on 2025-08-28. It is manufactured by Syrma Johari Medtech Limited. The 510(k) number is K251594.

When was truFlex approved by the FDA?

truFlex received FDA 510(k) clearance on 2025-08-28, under approval number K251594.

What company makes truFlex?

truFlex is manufactured by Syrma Johari Medtech Limited.

What is the FDA product code for truFlex?

The FDA product code for truFlex is NGX.

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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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