Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Ezlymph, Ezlymph M

K-Number: K193662 · 2021-02-11

ApplicantEezcare Medical Corp
Decision Date2021-02-11
Product CodeJOW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Ezlymph, Ezlymph M is the device name listed in this FDA 510(k) record. The listed applicant is Eezcare Medical Corp. It received FDA 510(k) clearance on 2021-02-11 under 510(k) number K193662. 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 Ezlymph, Ezlymph M?

Ezlymph, Ezlymph M is a medical device that received FDA 510(k) clearance on 2021-02-11. The listed applicant is Eezcare Medical Corp. The 510(k) number is K193662.

When did Ezlymph, Ezlymph M receive FDA 510(k) clearance?

Ezlymph, Ezlymph M received FDA 510(k) clearance on 2021-02-11, under 510(k) number K193662.

Who is the listed applicant for Ezlymph, Ezlymph M?

The FDA 510(k) record lists Eezcare Medical Corp as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Ezlymph, Ezlymph M?

The FDA product code for Ezlymph, Ezlymph M is JOW.

Other records listing Eezcare Medical Corp 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.

K191937Ezvena IPC, Ezvena SQS

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.

↑