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FDA 510(k)

COMPRESSIBLE LIMB AND CIRCULATION THERAPY SYSTEM

K-Number: K112441 · 2012-01-17

Decision Date2012-01-17
Product CodeIRP
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

COMPRESSIBLE LIMB AND CIRCULATION THERAPY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Daesung Maref Co., Ltd.. It received FDA 510(k) clearance on 2012-01-17 under 510(k) number K112441. 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 COMPRESSIBLE LIMB AND CIRCULATION THERAPY SYSTEM?

COMPRESSIBLE LIMB AND CIRCULATION THERAPY SYSTEM is a medical device that received FDA 510(k) clearance on 2012-01-17. The listed applicant is Daesung Maref Co., Ltd.. The 510(k) number is K112441.

When did COMPRESSIBLE LIMB AND CIRCULATION THERAPY SYSTEM receive FDA 510(k) clearance?

COMPRESSIBLE LIMB AND CIRCULATION THERAPY SYSTEM received FDA 510(k) clearance on 2012-01-17, under 510(k) number K112441.

Who is the listed applicant for COMPRESSIBLE LIMB AND CIRCULATION THERAPY SYSTEM?

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

What is the FDA product code for COMPRESSIBLE LIMB AND CIRCULATION THERAPY SYSTEM?

The FDA product code for COMPRESSIBLE LIMB AND CIRCULATION THERAPY SYSTEM is IRP.

Related Clinical Trials

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.

Other records listing Daesung Maref 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.

View all 13 devices →

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

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