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FDA 510(k)

Enhanced External Counter Pulsation Device Plus Omay-A

K-Number: K191955 · 2020-08-05

ApplicantOmay(Guangzhou)Med Technologies Co., Ltd.
Decision Date2020-08-05
Product CodeDRN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Enhanced External Counter Pulsation Device Plus Omay-A is a medical device manufactured by Omay(Guangzhou)Med Technologies Co., Ltd.. It received FDA 510(k) clearance on 2020-08-05 under approval number K191955. The device is classified under product code DRN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Enhanced External Counter Pulsation Device Plus Omay-A?

Enhanced External Counter Pulsation Device Plus Omay-A is a medical device that received FDA 510(k) clearance on 2020-08-05. It is manufactured by Omay(Guangzhou)Med Technologies Co., Ltd.. The 510(k) number is K191955.

When was Enhanced External Counter Pulsation Device Plus Omay-A approved by the FDA?

Enhanced External Counter Pulsation Device Plus Omay-A received FDA 510(k) clearance on 2020-08-05, under approval number K191955.

What company makes Enhanced External Counter Pulsation Device Plus Omay-A?

Enhanced External Counter Pulsation Device Plus Omay-A is manufactured by Omay(Guangzhou)Med Technologies Co., Ltd..

What is the FDA product code for Enhanced External Counter Pulsation Device Plus Omay-A?

The FDA product code for Enhanced External Counter Pulsation Device Plus Omay-A is DRN.

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Related PubMed Literature

PMID: 42204020 A Minimal UDI-DICOM Mapping Profile and Validation Artifact for Medical-Device Imaging Workflows. Journal of imaging informatics in medicine (2026) PMID: 41613162 Evaluating Translational AI: A Two-Way Moving Target Problem. NEJM AI (2025) PMID: 40775988 B-onic Suite: An Integrated Platform for Personalized Medical Devices, Real-Time Surgical Planning, and Enhanced Intraoperative Navigation. Studies in health technology and informatics (2025) PMID: 39834141 Evaluating the Safety and Usability of an Over-the-Counter Medical Device for Adults With Mild to Moderate Hearing Loss: Formative and Summative Usability Testing. JMIR human factors (2025)

Related Devices (Code: DRN)

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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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