FDA 510(k)

Perifit Care+

K 號：K231780 · 2023-12-20

決定日期2023-12-20

產品代碼HIR

諮詢委員會OB設備之醫療設備規範文本翻譯如下：關於OB設備的醫療設備規範文件：此設備已通過FDA認證，並獲得510(k)許可證。該設備的PMA申請已提交，並在NCT登錄編號為[編號]的研究中進行測試。相關文獻的PMID編號為[編號]。請參考以下識別碼和網址：識別碼：[識別碼] 網址：[網址] 政策：醫療規範-v1

決定相當於

器材摘要

Perifit Care+ is the device name listed in this FDA 510(k) record. The listed applicant is X6 Innovations. It received FDA 510(k) clearance on 2023-12-20 under 510(k) number K231780. The device is classified under product code HIR. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Perifit Care+?

Perifit Care+ is a medical device that received FDA 510(k) clearance on 2023-12-20. The listed applicant is X6 Innovations. The 510(k) number is K231780.

When did Perifit Care+ receive FDA 510(k) clearance?

Perifit Care+ received FDA 510(k) clearance on 2023-12-20, under 510(k) number K231780.

Who is the listed applicant for Perifit Care+?

The FDA 510(k) record lists X6 Innovations as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Perifit Care+?

The FDA product code for Perifit Care+ is HIR.

其他以 X6 Innovations 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。

K231785Perifit 泵 K221476Perifit

相關器械（代碼：HIR）

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。

K252748骨盆底練習器（PF01）Hunan Accurate Bio-Medical Technology Co., Ltd.K240805飛行機械治療系統，MTI-1.5（MTI-1.5）Pelvital USA, Inc.K231875陰道觸覺超音波影像儀Advanced Tactile Imaging, Inc.K233362飛行機械治療系統（別稱飛行系統）（MTI-1.0）Pelvital USA, Inc.K221476PerifitX6 Innovations K213913leva 盆腔健康系統Renovia, Inc.

官方來源

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