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FDA 510(k)

medi pneumatic compression system (pcs) – brio (Model 651)

K-Number: K183631 · 2019-01-25

ApplicantMedi USA, LP
Decision Date2019-01-25
Product CodeJOW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

medi pneumatic compression system (pcs) – brio (Model 651) is the device name listed in this FDA 510(k) record. The listed applicant is Medi USA, LP. It received FDA 510(k) clearance on 2019-01-25 under 510(k) number K183631. 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 medi pneumatic compression system (pcs) – brio (Model 651)?

medi pneumatic compression system (pcs) – brio (Model 651) is a medical device that received FDA 510(k) clearance on 2019-01-25. The listed applicant is Medi USA, LP. The 510(k) number is K183631.

When did medi pneumatic compression system (pcs) – brio (Model 651) receive FDA 510(k) clearance?

medi pneumatic compression system (pcs) – brio (Model 651) received FDA 510(k) clearance on 2019-01-25, under 510(k) number K183631.

Who is the listed applicant for medi pneumatic compression system (pcs) – brio (Model 651)?

The FDA 510(k) record lists Medi USA, LP as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for medi pneumatic compression system (pcs) – brio (Model 651)?

The FDA product code for medi pneumatic compression system (pcs) – brio (Model 651) is JOW.

Other records listing Medi USA, LP 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.

K221654medi pneumatic compression system (pcs)-genius (Model 652)

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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