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FDA 510(k)

COMPRESSIBLE LIMB THERAPY SYSTEM MODEL WHF-324 (POWER-Q1000 PLUS)

K-Number: K100656 · 2010-05-26

ApplicantWonjin Mulsan Co., Ltd.
Decision Date2010-05-26
Product CodeIRP
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

COMPRESSIBLE LIMB THERAPY SYSTEM MODEL WHF-324 (POWER-Q1000 PLUS) is the device name listed in this FDA 510(k) record. The listed applicant is Wonjin Mulsan Co., Ltd.. It received FDA 510(k) clearance on 2010-05-26 under 510(k) number K100656. 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 THERAPY SYSTEM MODEL WHF-324 (POWER-Q1000 PLUS)?

COMPRESSIBLE LIMB THERAPY SYSTEM MODEL WHF-324 (POWER-Q1000 PLUS) is a medical device that received FDA 510(k) clearance on 2010-05-26. The listed applicant is Wonjin Mulsan Co., Ltd.. The 510(k) number is K100656.

When did COMPRESSIBLE LIMB THERAPY SYSTEM MODEL WHF-324 (POWER-Q1000 PLUS) receive FDA 510(k) clearance?

COMPRESSIBLE LIMB THERAPY SYSTEM MODEL WHF-324 (POWER-Q1000 PLUS) received FDA 510(k) clearance on 2010-05-26, under 510(k) number K100656.

Who is the listed applicant for COMPRESSIBLE LIMB THERAPY SYSTEM MODEL WHF-324 (POWER-Q1000 PLUS)?

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

What is the FDA product code for COMPRESSIBLE LIMB THERAPY SYSTEM MODEL WHF-324 (POWER-Q1000 PLUS)?

The FDA product code for COMPRESSIBLE LIMB THERAPY SYSTEM MODEL WHF-324 (POWER-Q1000 PLUS) 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.

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Other records listing Wonjin Mulsan 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.

K211283Compressible Limb and Circulation Therapy System, Model POWER-Q2300K200660Compressible Limb and Circulation Therapy SystemK113275COMPRESSIBLE LIMB THERAPY SYSTEMK080134COMPRESSIBLE LIMB AND CIRCULATION THERAPY SYSTEM, MODEL WHF-314 (POWER-Q1000)

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.

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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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