FDA 510(k)

Perifit

K 號：K221476 · 2023-02-10

決定日期2023-02-10

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 is the device name listed in this FDA 510(k) record. The listed applicant is X6 Innovations. It received FDA 510(k) clearance on 2023-02-10 under 510(k) number K221476. 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?

Perifit is a medical device that received FDA 510(k) clearance on 2023-02-10. The listed applicant is X6 Innovations. The 510(k) number is K221476.

When did Perifit receive FDA 510(k) clearance?

Perifit received FDA 510(k) clearance on 2023-02-10, under 510(k) number K221476.

Who is the listed applicant for Perifit?

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?

The FDA product code for Perifit 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 K231780Perifit Care+

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.K231780Perifit Care+X6 Innovations K213913leva 盆腔健康系統Renovia, Inc.

官方來源

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