FDA 510(k)

無線疼痛緩解設備型號：LT5018C

K 號：K173462 · 2017-12-08

申請人Shenzhen Dongdixin Technology Co., Ltd.

決定日期2017-12-08

產品代碼NUH

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

Wireless Pain Relieve Device Model: LT5018C is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Dongdixin Technology Co., Ltd.. It received FDA 510(k) clearance on 2017-12-08 under 510(k) number K173462. The device is classified under product code NUH. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Wireless Pain Relieve Device Model: LT5018C?

Wireless Pain Relieve Device Model: LT5018C is a medical device that received FDA 510(k) clearance on 2017-12-08. The listed applicant is Shenzhen Dongdixin Technology Co., Ltd.. The 510(k) number is K173462.

When did Wireless Pain Relieve Device Model: LT5018C receive FDA 510(k) clearance?

Wireless Pain Relieve Device Model: LT5018C received FDA 510(k) clearance on 2017-12-08, under 510(k) number K173462.

Who is the listed applicant for Wireless Pain Relieve Device Model: LT5018C?

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

What is the FDA product code for Wireless Pain Relieve Device Model: LT5018C?

The FDA product code for Wireless Pain Relieve Device Model: LT5018C is NUH.

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