FDA 510(k)

テンセランス電極

K番号: K160081 · 2016-10-19

決定日2016-10-19

製品コードGXY

諮問委員会Please provide the source text to translate.

決定大幅同等

医療機器の概要

TENS Electrodes is the device name listed in this FDA 510(k) record. The listed applicant is Cathay Manufacturing Corp.. It received FDA 510(k) clearance on 2016-10-19 under 510(k) number K160081. The device is classified under product code GXY. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the TENS Electrodes?

TENS Electrodes is a medical device that received FDA 510(k) clearance on 2016-10-19. The listed applicant is Cathay Manufacturing Corp.. The 510(k) number is K160081.

When did TENS Electrodes receive FDA 510(k) clearance?

TENS Electrodes received FDA 510(k) clearance on 2016-10-19, under 510(k) number K160081.

Who is the listed applicant for TENS Electrodes?

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

What is the FDA product code for TENS Electrodes?

The FDA product code for TENS Electrodes is GXY.

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テンセランス電極

医療機器の概要

よくある質問

関連する臨床試験

関連機器（コード：GXY）

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