FDA 510(k)

Cionic神經袖套 NS-100

K 號：K221823 · 2022-07-21

申請人Cionic

決定日期2022-07-21

產品代碼GZI

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

Cionic Neural Sleeve NS-100 is the device name listed in this FDA 510(k) record. The listed applicant is Cionic. It received FDA 510(k) clearance on 2022-07-21 under 510(k) number K221823. The device is classified under product code GZI. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Cionic Neural Sleeve NS-100?

Cionic Neural Sleeve NS-100 is a medical device that received FDA 510(k) clearance on 2022-07-21. The listed applicant is Cionic. The 510(k) number is K221823.

When did Cionic Neural Sleeve NS-100 receive FDA 510(k) clearance?

Cionic Neural Sleeve NS-100 received FDA 510(k) clearance on 2022-07-21, under 510(k) number K221823.

Who is the listed applicant for Cionic Neural Sleeve NS-100?

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

What is the FDA product code for Cionic Neural Sleeve NS-100?

The FDA product code for Cionic Neural Sleeve NS-100 is GZI.

其他以 Cionic 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。

K213622Cionic神經袖套 NS-100

相關器械（代碼：GZI）

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。

K242704Synchrony (20-3000)Synapse Biomedical, Inc.K243828CIONIC神經袖套（NS-200）Cionic, Inc.K240632Neuvotion NeuStim NN-01Neuvotion, Inc.K233006MyndMove, MyndMove 2.0Myndtec, Inc.K230997EvoWalk 1.0 系統Evolution Devices, Inc.K213925MyoCycle MC-2 (家庭 / 家庭+ / 職業 / 職業+)Myolyn, LLC

官方來源

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