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FDA 510(k)

Heat StimPlus

K-Number: K212918 · 2021-12-13

Decision Date2021-12-13
Product CodeNUH
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Heat StimPlus is the device name listed in this FDA 510(k) record. The listed applicant is Famidoc Technology Co., Ltd.. It received FDA 510(k) clearance on 2021-12-13 under 510(k) 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. The listed applicant is Famidoc Technology Co., Ltd.. The 510(k) number is K212918.

When did Heat StimPlus receive FDA 510(k) clearance?

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

Who is the listed applicant for Heat StimPlus?

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

What is the FDA product code for Heat StimPlus?

The FDA product code for Heat StimPlus is NUH.

Other records listing Famidoc Technology Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Related Devices (Code: NUH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Official Source

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