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FDA 510(k)

Ems Foot Stimulator (model: HK701, HK701A, HK701B, HK701C)

K-Number: K221251 · 2022-07-29

ApplicantGuangzhou Huakai Electronic Technology Co., Ltd.
Decision Date2022-07-29
Product CodeNUH
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Ems Foot Stimulator (model: HK701, HK701A, HK701B, HK701C) is a medical device manufactured by Guangzhou Huakai Electronic Technology Co., Ltd.. It received FDA 510(k) clearance on 2022-07-29 under approval number K221251. The device is classified under product code NUH. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Ems Foot Stimulator (model: HK701, HK701A, HK701B, HK701C)?

Ems Foot Stimulator (model: HK701, HK701A, HK701B, HK701C) is a medical device that received FDA 510(k) clearance on 2022-07-29. It is manufactured by Guangzhou Huakai Electronic Technology Co., Ltd.. The 510(k) number is K221251.

When was Ems Foot Stimulator (model: HK701, HK701A, HK701B, HK701C) approved by the FDA?

Ems Foot Stimulator (model: HK701, HK701A, HK701B, HK701C) received FDA 510(k) clearance on 2022-07-29, under approval number K221251.

What company makes Ems Foot Stimulator (model: HK701, HK701A, HK701B, HK701C)?

Ems Foot Stimulator (model: HK701, HK701A, HK701B, HK701C) is manufactured by Guangzhou Huakai Electronic Technology Co., Ltd..

What is the FDA product code for Ems Foot Stimulator (model: HK701, HK701A, HK701B, HK701C)?

The FDA product code for Ems Foot Stimulator (model: HK701, HK701A, HK701B, HK701C) is NUH.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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