FDA 510(k)

Smart Pulse Relief (PZ-2622, PZ-2622T, PZ-2622E)

Número K: K250033 · 2025-04-07

RequerenteGuangzhou Pinzhi Medical Technology Co., Ltd.

Data da decisão2025-04-07

Código do produtoNUH

Comité consultivoNE

DecisãoSubstantially Equivalent

Resumo do dispositivo

Smart Pulse Relief (PZ-2622, PZ-2622T, PZ-2622E) is the device name listed in this FDA 510(k) record. The listed applicant is Guangzhou Pinzhi Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2025-04-07 under 510(k) number K250033. The device is classified under product code NUH. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Smart Pulse Relief (PZ-2622, PZ-2622T, PZ-2622E)?

Smart Pulse Relief (PZ-2622, PZ-2622T, PZ-2622E) is a medical device that received FDA 510(k) clearance on 2025-04-07. The listed applicant is Guangzhou Pinzhi Medical Technology Co., Ltd.. The 510(k) number is K250033.

When did Smart Pulse Relief (PZ-2622, PZ-2622T, PZ-2622E) receive FDA 510(k) clearance?

Smart Pulse Relief (PZ-2622, PZ-2622T, PZ-2622E) received FDA 510(k) clearance on 2025-04-07, under 510(k) number K250033.

Who is the listed applicant for Smart Pulse Relief (PZ-2622, PZ-2622T, PZ-2622E)?

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

What is the FDA product code for Smart Pulse Relief (PZ-2622, PZ-2622T, PZ-2622E)?

The FDA product code for Smart Pulse Relief (PZ-2622, PZ-2622T, PZ-2622E) is NUH.

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