FDA 510(k)

包装附件电极

K号: K210383 · 2021-11-12

决定日期2021-11-12

产品代码GXY

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决定实质等同

器械摘要

Wrap Accessory Electrodes is the device name listed in this FDA 510(k) record. The listed applicant is Hi-Dow International, Inc.. It received FDA 510(k) clearance on 2021-11-12 under 510(k) number K210383. The device is classified under product code GXY. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Wrap Accessory Electrodes?

Wrap Accessory Electrodes is a medical device that received FDA 510(k) clearance on 2021-11-12. The listed applicant is Hi-Dow International, Inc.. The 510(k) number is K210383.

When did Wrap Accessory Electrodes receive FDA 510(k) clearance?

Wrap Accessory Electrodes received FDA 510(k) clearance on 2021-11-12, under 510(k) number K210383.

Who is the listed applicant for Wrap Accessory Electrodes?

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

What is the FDA product code for Wrap Accessory Electrodes?

The FDA product code for Wrap Accessory Electrodes is GXY.

列明Hi-Dow International, Inc.为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K233461Hi-Dow PRO TOUCH WIRELESS 6-12 (HD-19A)K202337脉冲电磁场敷料 K190617包裹辅助电极 K163393Hi-Dow Wireless TENS/EMS System (Model HD-5N)

相关器械（代码：GXY）

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

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