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510(k) K191955

Enhanced External Counter Pulsation Device Plus Omay-A by Omay(Guangzhou)Med Technologies Co., Ltd. — Product Code DRN

K191955 is an FDA 510(k) premarket notification submitted by Omay(Guangzhou)Med Technologies Co., Ltd. for the device "Enhanced External Counter Pulsation Device Plus Omay-A". The FDA issued a decision of Substantially Equivalent on August 5, 2020. The device falls under product code DRN (Device, Counter-Pulsating, External), a Class II device regulated under 21 CFR 870.5225.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 5, 2020
Date Received
July 22, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Counter-Pulsating, External
Device Class
Class II
Regulation Number
870.5225
Review Panel
CV
Submission Type

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  • K152115 — Renew NCP-5 External Counterpulsation System (December 17, 2015)
  • K130439 — EXTERNAL COUNTERPULSATION DEVICE WITH SP02 MORNITORING (December 12, 2013)
  • K082134 — CIRCULATOR BOOT (May 7, 2009)
  • K081359 — GENESIS ECP (May 29, 2008)
  • K052611 — ECP HEALTH SYSTEM, MODEL 2005 (April 26, 2006)
  • K050172 — CARDIASSIST COUNTER PULSATION SYSTEM SERIES 4000/5000 (March 31, 2005)

FDA data resources