FDA 510(k)

Unipro (K-UNIPRO-US)

K 號：K232441 · 2024-08-30

決定日期2024-08-30

產品代碼GZJ

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

Unipro (K-UNIPRO-US) is the device name listed in this FDA 510(k) record. The listed applicant is Tenscare, Ltd.. It received FDA 510(k) clearance on 2024-08-30 under 510(k) number K232441. The device is classified under product code GZJ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Unipro (K-UNIPRO-US)?

Unipro (K-UNIPRO-US) is a medical device that received FDA 510(k) clearance on 2024-08-30. The listed applicant is Tenscare, Ltd.. The 510(k) number is K232441.

When did Unipro (K-UNIPRO-US) receive FDA 510(k) clearance?

Unipro (K-UNIPRO-US) received FDA 510(k) clearance on 2024-08-30, under 510(k) number K232441.

Who is the listed applicant for Unipro (K-UNIPRO-US)?

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

What is the FDA product code for Unipro (K-UNIPRO-US)?

The FDA product code for Unipro (K-UNIPRO-US) is GZJ.

其他以 Tenscare, 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。

K230926Ova+ (K-OVAP-USA)K230983Unicare (K-UNICARE-USA)K231053Unicare (K-UNICARE-USA)K200694完美電子肌肉刺激器 FDA、510(k)、PMA、NCT、PMID、識別碼及網址請參考原文。K191312完美PFE

相關器械（代碼：GZJ）

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。

K252712STIMPOD NMS460 神經刺激器Algiamed Technologies USA, Inc.K252767actiTENS迷你版Sublimed K252236CP緩解棒Rx - TENS/NMESN & C Holdings, LLC K241228TENSWaveZynex Medical Officer K233046電氣神經肌肉刺激器，治療三合一Oriental Inspiration Limited K222879經皮電神經刺激器（型號：TENS WMPS6-1）Wuxi Jiajian Medical Instrument Co., Ltd.

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。