Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

ThermArt (Model IR-EFT)

K-Number: K202481 · 2021-09-28

Decision Date2021-09-28
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

ThermArt (Model IR-EFT) is the device name listed in this FDA 510(k) record. The listed applicant is Comper Chuangxiang (Beijing) Technology Co., Ltd.. It received FDA 510(k) clearance on 2021-09-28 under 510(k) number K202481. The device is classified under product code FLL. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ThermArt (Model IR-EFT)?

ThermArt (Model IR-EFT) is a medical device that received FDA 510(k) clearance on 2021-09-28. The listed applicant is Comper Chuangxiang (Beijing) Technology Co., Ltd.. The 510(k) number is K202481.

When did ThermArt (Model IR-EFT) receive FDA 510(k) clearance?

ThermArt (Model IR-EFT) received FDA 510(k) clearance on 2021-09-28, under 510(k) number K202481.

Who is the listed applicant for ThermArt (Model IR-EFT)?

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

What is the FDA product code for ThermArt (Model IR-EFT)?

The FDA product code for ThermArt (Model IR-EFT) is FLL.

Other records listing Comper Chuangxiang (Beijing) 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: FLL)

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

View on FDA Database →

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