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FDA 510(k)

Heat StimPlus

K-Number: K212918 · 2021-12-13

ApplicantFamidoc Technology Co., Ltd.
Decision Date2021-12-13
Product CodeNUH
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Heat StimPlus is a medical device manufactured by Famidoc Technology Co., Ltd.. It received FDA 510(k) clearance on 2021-12-13 under approval number K212918. 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 Heat StimPlus?

Heat StimPlus is a medical device that received FDA 510(k) clearance on 2021-12-13. It is manufactured by Famidoc Technology Co., Ltd.. The 510(k) number is K212918.

When was Heat StimPlus approved by the FDA?

Heat StimPlus received FDA 510(k) clearance on 2021-12-13, under approval number K212918.

What company makes Heat StimPlus?

Heat StimPlus is manufactured by Famidoc Technology Co., Ltd..

What is the FDA product code for Heat StimPlus?

The FDA product code for Heat StimPlus 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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