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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 the device name listed in this FDA 510(k) record. The listed applicant is Syrma Johari Medtech Limited. It received FDA 510(k) clearance on 2025-08-28 under 510(k) 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. The listed applicant is Syrma Johari Medtech Limited. The 510(k) number is K251594.

When did truFlex receive FDA 510(k) clearance?

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

Who is the listed applicant for truFlex?

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

What is the FDA product code for truFlex?

The FDA product code for truFlex is NGX.

Related Devices (Code: NGX)

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.

K253790High Intensity Focused Electromagnetic Stimulation Device (FE60)Beijing Winkonlaser Technology LimitedK253926DiacoreShenB Co., Ltd.K253636Zionic Pro Max (EMS)Termosalud S.L.K253408CoolToneZimmer Medizinsysteme GmbHK252154Portable Electro Stimulation Therapy Device (LGT-2320BE, LGT-2320ME, and LGT-2320SP)Guangzhou Longest Medical Technology Co., Ltd.K253478Motive™ Muscle Stimulator for Lower Back (OT01-1003)Motive Health, Inc.

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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