FDA 510(k)

主要緩解

K 號：K221425 · 2022-09-13

決定日期2022-09-13

產品代碼NHI

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

Primary Relief is the device name listed in this FDA 510(k) record. The listed applicant is Dyansys, Inc.. It received FDA 510(k) clearance on 2022-09-13 under 510(k) number K221425. The device is classified under product code NHI. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Primary Relief?

Primary Relief is a medical device that received FDA 510(k) clearance on 2022-09-13. The listed applicant is Dyansys, Inc.. The 510(k) number is K221425.

When did Primary Relief receive FDA 510(k) clearance?

Primary Relief received FDA 510(k) clearance on 2022-09-13, under 510(k) number K221425.

Who is the listed applicant for Primary Relief?

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

What is the FDA product code for Primary Relief?

The FDA product code for Primary Relief is NHI.

其他以 Dyansys, Inc. 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。

K221231藥物緩解 v1 K220397ANSiStim-PP K213188主要緩解 K212859First Relief K211971藥物緩解 v1 K202940第一緩解 v1

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相關器械（代碼：NHI）

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。

K223306SPRINT 周邊神經刺激（PNS）系統Spr Therapeutics, Inc.K220397ANSiStim-PPDyansys, Inc.K213188主要緩解Dyansys, Inc.K212859First ReliefDyansys, Inc.K211801SPRINT神經系統系統Spr Therapeutics, Inc.K202660SPRINT神經系統系統Spr Therapeutics, Inc.

官方來源

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