FDA 510(k)

NeuroTrac® MyoPlus Pro (MYO120U)

Número K: K243079 · 2025-06-26

Data da decisão2025-06-26

Código do produtoKPI

Comité consultivoGU

DecisãoSubstantially Equivalent

Resumo do dispositivo

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.

Perguntas frequentes

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.

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