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FDA 510(k)

Intermittent Pneumatic Compression system

K-Number: K160180 · 2016-11-03

ApplicantDaesung Maref Co., Ltd.
Decision Date2016-11-03
Product CodeJOW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Intermittent Pneumatic Compression 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 2016-11-03 under 510(k) number K160180. The device is classified under product code JOW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Intermittent Pneumatic Compression system?

Intermittent Pneumatic Compression system is a medical device that received FDA 510(k) clearance on 2016-11-03. The listed applicant is Daesung Maref Co., Ltd.. The 510(k) number is K160180.

When did Intermittent Pneumatic Compression system receive FDA 510(k) clearance?

Intermittent Pneumatic Compression system received FDA 510(k) clearance on 2016-11-03, under 510(k) number K160180.

Who is the listed applicant for Intermittent Pneumatic Compression 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 Intermittent Pneumatic Compression system?

The FDA product code for Intermittent Pneumatic Compression system is JOW.

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.

NCT03871075Intermittent Pneumatic Compression With and Without Exercise to Improve Functioning in Peripheral Artery DiseaseACTIVE_NOT_RECRUITINGNCT05491109Soft Robotic Sock Intervention for Robot-assisted Ankle-foot Mobility in Post-stroke PatientsCOMPLETEDNCT06815367Pneumatic Compression vs Blood Flow Restriction for Muscle RecoveryRECRUITINGNCT07573189The Effects of Recovery Compression Boots on Blood Lactate Levels, Functional Movement, and Joint Ange of Motion in Collegiate Athletes.ACTIVE_NOT_RECRUITING

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.

K231437LF900K202395SP-1000, SP-2000K203498LX9maxK203019LF900K203353DVT-PROK203417DVT-4000S

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Related Devices (Code: JOW)

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.

K253555Flexitouch® Plus Advanced Pneumatic Compression SystemTactile MedicalK253386DVT GarmentVistar Medical Supplies Co., Ltd.K250242Compression Therapy Device (LGT-2202DVT)Guangzhou Longest Medical Technology Co., Ltd.K254267NanoPress 760A-BT (760A-BT)Mego Afek , Ltd.K250974Bio Arterial Deluxe (IC-BAP-DX)Bio Compression Systems, Inc.K250190Sequential Compression System (SCD600)Shenzhen Comen Medical Instruments Co.,Ltd

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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