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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

ApplicantFoshan Hongfeng Co., Ltd.
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 a medical device manufactured by Foshan Hongfeng Co., Ltd.. It received FDA 510(k) clearance on 2021-03-25 under approval 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. It is manufactured by Foshan Hongfeng Co., Ltd.. The 510(k) number is K201982.

When was Air compression therapy system FO-3001; Air compression therapy system FO-3008 approved by the FDA?

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

What company makes 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 manufactured by Foshan Hongfeng Co., Ltd..

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.

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Related PubMed Literature

PMID: 41966529 Comparison of the AccuPower HIV-1 Quant Kit and Aptima HIV-1 Quant Dx Assay for quantification of HIV-1 plasma viral load. Diagnostic microbiology and infectious disease (2026) PMID: 40942702 Digital Cardiovascular Twins, AI Agents, and Sensor Data: A Narrative Review from System Architecture to Proactive Heart Health. Sensors (Basel, Switzerland) (2025) PMID: 40624966 Peptide-Enhanced Bioactive Hydrogel Combined with Photodynamic-Phage Synergistic Antibacterial Therapy System Accelerates Infected Wound Healing. Advanced healthcare materials (2025)

Other Devices by Foshan Hongfeng Co., Ltd.

K212169Air compression therapy system FO3002

Related Devices (Code: IRP)

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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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