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FDA 510(k)

Air compression therapy system FO-3001; Air compression therapy system FO-3008

K-Number: K201982 · 2021-03-25

Decision Date2021-03-25
Product CodeIRP
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

Air compression therapy system FO-3001; Air compression therapy system FO-3008 is the device name listed in this FDA 510(k) record. The listed applicant is Foshan Hongfeng Co., Ltd.. It received FDA 510(k) clearance on 2021-03-25 under 510(k) number K201982. The device is classified under product code IRP. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Air compression therapy system FO-3001; Air compression therapy system FO-3008?

Air compression therapy system FO-3001; Air compression therapy system FO-3008 is a medical device that received FDA 510(k) clearance on 2021-03-25. The listed applicant is Foshan Hongfeng Co., Ltd.. The 510(k) number is K201982.

When did Air compression therapy system FO-3001; Air compression therapy system FO-3008 receive FDA 510(k) clearance?

Air compression therapy system FO-3001; Air compression therapy system FO-3008 received FDA 510(k) clearance on 2021-03-25, under 510(k) number K201982.

Who is the listed applicant for Air compression therapy system FO-3001; Air compression therapy system FO-3008?

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

What is the FDA product code for Air compression therapy system FO-3001; Air compression therapy system FO-3008?

The FDA product code for Air compression therapy system FO-3001; Air compression therapy system FO-3008 is IRP.

Other records listing Foshan Hongfeng 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: IRP)

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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