FDA 510(k)

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

Номер K: K250033 · 2025-04-07

ЗаявительGuangzhou Pinzhi Medical Technology Co., Ltd.

Дата решения2025-04-07

Код продуктаNUH

Консультативный комитетNE

РешениеSubstantially Equivalent

Описание устройства

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.

Часто задаваемые вопросы

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.

Связанные клинические исследования

Связанные записи сопоставляются автоматически на основании названий, кодов продукции или иных метаданных. Сопоставление не подтверждает клиническую, научную, корпоративную или регуляторную связь; ознакомьтесь с официальными источниками по ссылкам.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Связанные устройства (Код: NUH)

K261131Electrical Muscle Stimulator (AST-105DJ, AST-105EJ, AST- 105BJ, AST-105GJ, AST-303J, AST-309J, AST-310J;AST-300Q, AST-300Q-A, AST-500B; AST-500G, AST-500F; AST-500N; AST- 500C, AST- 500K, AST-500A; AST-300E, AST-500M, AST- 500U, AST- 500D; AST- 500E.)Shenzhen Osto Medical Technology Co.,Ltd K260412TENS 7000 Rechargeable 4 Channel (TENS 7000H)Shenzhen Dongdixin Technology Co., Ltd.K260425TENS / EMS DEVICE (FT-247 Series) (FT-247, FT-237)Hivox Biotek, Inc.K253896TENS/EMS device (GUSE01)Globalcare Medical Technology Co., Ltd.K253305TENS AND EMS (TENS and Muscle Stimulator) (JT1065, JT1080, JT2080, JT9034)Shenzhen Jiantuo Electronics Co., Ltd.K253740TENS&EMS (HZ9151B, HZ9151C, HZ9151D)Hong Qiangxing (Shenzhen) Electronics Limited

Официальный источник

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