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FDA 510(k)

NeuroTrac® MyoPlus Pro (MYO120U)

K-Number: K243079 · 2025-06-26

ApplicantVerity Medical , Ltd.
Decision Date2025-06-26
Product CodeKPI
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

NeuroTrac® MyoPlus Pro (MYO120U) is the device name listed in this FDA 510(k) record. The listed applicant is Verity Medical , Ltd.. It received FDA 510(k) clearance on 2025-06-26 under 510(k) number K243079. The device is classified under product code KPI. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NeuroTrac® MyoPlus Pro (MYO120U)?

NeuroTrac® MyoPlus Pro (MYO120U) is a medical device that received FDA 510(k) clearance on 2025-06-26. The listed applicant is Verity Medical , Ltd.. The 510(k) number is K243079.

When did NeuroTrac® MyoPlus Pro (MYO120U) receive FDA 510(k) clearance?

NeuroTrac® MyoPlus Pro (MYO120U) received FDA 510(k) clearance on 2025-06-26, under 510(k) number K243079.

Who is the listed applicant for NeuroTrac® MyoPlus Pro (MYO120U)?

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

What is the FDA product code for NeuroTrac® MyoPlus Pro (MYO120U)?

The FDA product code for NeuroTrac® MyoPlus Pro (MYO120U) is KPI.

Related Devices (Code: KPI)

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.

K260178Pelvic Muscle Trainer (KM510, KM516B)Shenzhen Konmed Technology Co., Ltd.K252601Pelvic Muscle Trainer (PC22A); Pelvic Muscle Trainer (PC22A-L); Pelvic Muscle Trainer (PC22E); Pelvic Muscle Trainer (PC22E-L)Hunan Accurate Bio-Medical Technology Co., Ltd.K252552Pelvic Floor Rehabilitation Therapy Device (PD2301/PD2302/PD2303)Shenzhen Changkun Technology Co., Ltd.K252831Pelvic Floor Treatment Device (DLR-8920, DLR-8921, DLR-8922, DLR-8923, DLR-8924, DLR-8925, DLR-8926, DLR-8927)Dolanvy (Suzhou) Medical Technology Co., Ltd.K252334PELVIPOWER Pelvic Functional Magnetic Stimulation (PELVIPOWER PelvicFMS) (033-0-1100-02)PontemedagK251760Well-Life Incontinence Stimulation System (WL-2405i(P))Well-Life Healthcare , Ltd.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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