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FDA 510(k)

Compressible Limb and Circulation Therapy System, Model POWER-Q2300

K-Number: K211283 · 2021-09-14

ApplicantWonjin Mulsan Co., Ltd.
Decision Date2021-09-14
Product CodeIRP
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

Compressible Limb and Circulation Therapy System, Model POWER-Q2300 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 2021-09-14 under 510(k) number K211283. 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, Model POWER-Q2300?

Compressible Limb and Circulation Therapy System, Model POWER-Q2300 is a medical device that received FDA 510(k) clearance on 2021-09-14. The listed applicant is Wonjin Mulsan Co., Ltd.. The 510(k) number is K211283.

When did Compressible Limb and Circulation Therapy System, Model POWER-Q2300 receive FDA 510(k) clearance?

Compressible Limb and Circulation Therapy System, Model POWER-Q2300 received FDA 510(k) clearance on 2021-09-14, under 510(k) number K211283.

Who is the listed applicant for Compressible Limb and Circulation Therapy System, Model POWER-Q2300?

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 and Circulation Therapy System, Model POWER-Q2300?

The FDA product code for Compressible Limb and Circulation Therapy System, Model POWER-Q2300 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.

NCT06469463Decoding Motor Imagery From Non-invasive Brain Recordings as a Prerequisite for Innovative Motor Rehabilitation TherapiesCOMPLETED

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.

K200660Compressible Limb and Circulation Therapy System

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.

K260944ManaCold Compression SystemManamed, LLCK260529Air Compression Massager (HY-1165)Xiamen High Top Electronic Technology Co., Ltd.K260948Air Compression Massager (EP30B001 I)Wavepulse (Xiamen) Healthcare Technology Co., Ltd.K253919Cryo And Thermo Therapy SystemXiamen Weiyou Intelligent Technology Co., Ltd.K252396Cryo Sport 2.0 (AVA 501)Avanutri Equipamentos DE SaúdeK254200Air Compression Leg Massager (LF-FT001, LF-FT002-1, LF-FT003, LF-FT003-1, LF-FT004-1, LF-FT005-1, LF-FT006-1, LF-FT007, LF-FT008, LF-FT009, LF-FT010, LF-FT011, LF-FT012, LF-FT013, LF-FT014, LF-FT015, LF-FT016, UM-01, UM-02, UM-03, UM-03-1, UM-04-1, UM-05-1, UM-06-1, UM-07, UM-08, UM-09, UM-10, UM-11, UM-12, UM-13, UM-14, UM-15, UM-16, AI-01, AI-02, AI-03, AI-04, AI-05, AI-06, AI01, AI02, AI03, AI-07, AI-08, AI-09, AI-10, AI-11, AI-12, AI-13, AI-14)Wenzhou Lingfeng Electronic Technology Co., Ltd.

Official Source

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