FDA 510(k)

電擊治療器 & 月經痛治療器

K 號：K201354 · 2020-12-11

申請人Hong Qiangxing (Shenzhen) Electronics Limited

決定日期2020-12-11

產品代碼NGX

諮詢委員會PM

決定相當於

器材摘要

TENS & PMS is the device name listed in this FDA 510(k) record. The listed applicant is Hong Qiangxing (Shenzhen) Electronics Limited. It received FDA 510(k) clearance on 2020-12-11 under 510(k) number K201354. 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 TENS & PMS?

TENS & PMS is a medical device that received FDA 510(k) clearance on 2020-12-11. The listed applicant is Hong Qiangxing (Shenzhen) Electronics Limited. The 510(k) number is K201354.

When did TENS & PMS receive FDA 510(k) clearance?

TENS & PMS received FDA 510(k) clearance on 2020-12-11, under 510(k) number K201354.

Who is the listed applicant for TENS & PMS?

The FDA 510(k) record lists Hong Qiangxing (Shenzhen) Electronics Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TENS & PMS?

The FDA product code for TENS & PMS is NGX.

其他以 Hong Qiangxing (Shenzhen) Electronics Limited 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。

K253740TENS&EMS (HZ9151B, HZ9151C, HZ9151D)K220283TENS & PMS（型號：SM9009、SM9021、SM9128H、SM9015、SM9055、SM9033）K220152TENS & PMS（型號：SM9089、SM9587、SM9592、SM9555）K220150TENS & PMS（型號：SM9126）K190009Sunmas TENS & PMS（型號 SM9187、SM9180L、SM9180S）K183154SM電極

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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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