免責聲明: 本站彙整 FDA、ClinicalTrials.gov、PubMed、SEC EDGAR 等官方公開資料，僅供一般參考，不構成醫療建議、診斷、治療建議或投資建議。

FDA 510(k)

智能脈搏舒緩器（PZ-2622、PZ-2622T、PZ-2622E）

K 號：K250033 · 2025-04-07

申請人Guangzhou Pinzhi Medical Technology Co., Ltd.
決定日期2025-04-07
產品代碼NUH
諮詢委員會NE (請提供完整的英文描述，以便進行翻譯。)
決定相當於

器材摘要

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.

常見問題

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.

相關臨床試驗

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

NCT07608549FLASH 預試階段 1 安全性研究NOT_YET_RECRUITINGNCT06562205PAP系統外部臨床研究（ECS）NOT_YET_RECRUITINGNCT06443177對於動脈瘤性硬腦膜下出血引起的腦血管收縮，交感調節的影響SUSPENDEDNCT07095751人工智能協助的Uro-Cam導尿管評估系統，用於診斷膀胱癌NOT_YET_RECRUITING

相關器械（代碼：NUH）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K261131電動肌肉刺激器（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.,LtdK260412TENS 7000 可充電 4 頻道 (TENS 7000H)Shenzhen Dongdixin Technology Co., Ltd.K260425TENS / EMS 裝置（FT-247 系列產品）（FT-247，FT-237）Hivox Biotek, Inc.K253896TENS/EMS 裝置（GUSE01）Globalcare Medical Technology Co., Ltd.K253305電擊療與電肌肉刺激器（TENS 和 Muscle Stimulator）(JT1065, JT1080, JT2080, JT9034)Shenzhen Jiantuo Electronics Co., Ltd.K253740TENS&EMS (HZ9151B, HZ9151C, HZ9151D)Hong Qiangxing (Shenzhen) Electronics Limited

官方來源

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。

↑