FDA 510(k)

疼痛治療設備（型號：P.T.S-X）

K 號：K230711 · 2024-05-16

決定日期2024-05-16

產品代碼NGX

諮詢委員會PM

決定相當於

器材摘要

Pain Therapy Device(Model: P.T.S-X) is the device name listed in this FDA 510(k) record. The listed applicant is Guangzhou Xinbo Electronic Co., Ltd.. It received FDA 510(k) clearance on 2024-05-16 under 510(k) number K230711. The device is classified under product code NGX. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Pain Therapy Device(Model: P.T.S-X)?

Pain Therapy Device(Model: P.T.S-X) is a medical device that received FDA 510(k) clearance on 2024-05-16. The listed applicant is Guangzhou Xinbo Electronic Co., Ltd.. The 510(k) number is K230711.

When did Pain Therapy Device(Model: P.T.S-X) receive FDA 510(k) clearance?

Pain Therapy Device(Model: P.T.S-X) received FDA 510(k) clearance on 2024-05-16, under 510(k) number K230711.

Who is the listed applicant for Pain Therapy Device(Model: P.T.S-X)?

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

What is the FDA product code for Pain Therapy Device(Model: P.T.S-X)?

The FDA product code for Pain Therapy Device(Model: P.T.S-X) is NGX.

其他以 Guangzhou Xinbo Electronic Co., Ltd. 為申請人之記錄

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。

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相關器械（代碼：NGX）

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。

K253790高強度聚焦電磁刺激器（FE60）Beijing Winkonlaser Technology Limited K253926迪阿科爾ShenB Co., Ltd.K253636Zionic Pro Max (電動肌肉刺激器)Termosalud S.L.K253408涼頻Zimmer Medizinsysteme GmbH K252154攜帶式電刺激治療設備（LGT-2320BE、LGT-2320ME 及 LGT-2320SP）Guangzhou Longest Medical Technology Co., Ltd.K253478Motive™ 腰部肌肉刺激器 (OT01-1003)Motive Health, Inc.

官方來源

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