510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K191955Substantially Equivalent

Enhanced External Counter Pulsation Device Plus Omay-A

Omay(guangzhou) Med Technologies Co., Ltd, Guangzhou, CN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K191955 is the FDA 510(k) clearance record for Enhanced External Counter Pulsation Device Plus Omay-A, a class II device, cleared for Omay(Guangzhou)Med Technologies Co., Ltd. on under FDA product code DRN (Device, Counter-Pulsating, External). FDA records list one 510(k) clearance for Omay(Guangzhou)Med Technologies Co., Ltd. As of , FDA records show no recalls naming K191955.

Clearance record

Decision date
Received
(380 days to decision)
Product code
DRN Device, Counter-Pulsating, External
Regulation
21 CFR 870.5225
Device class
Class II
Review panel
Cardiovascular
Applicant
Omay(Guangzhou)Med Technologies Co., Ltd. Rm. 302,3f, # 600-1, Guangshan 2nd Rd., Tianhe, Guangzhou, CN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code DRN

Trailing 12 months
1 clearance under product code DRN in the twelve months to October 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code DRN, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260