Feng Chun Yuan Medical Equipment (Shenzhen) Co., Ltd.

Shenzhen, CN

Feng Chun Yuan Medical Equipment (Shenzhen) Co., Ltd. appears in FDA device records in Shenzhen, CN. FDA records list one 510(k) clearance, no PMA records and no registered establishments. As of 2026-09-10, FDA records show 3 recalls for this company.

510(k) clearances: 1
PMA records: 0
Recall records: 3
Registered establishments: 0

510(k) clearance history

FDA records hold 1 510(k) clearance for Feng Chun Yuan Medical Equipment (Shenzhen) Co., Ltd. in 2021.

Clearances by year, as a table

510(k) clearance decisions for Feng Chun Yuan Medical Equipment (Shenzhen) Co., Ltd., by decision year
Year	Clearances
2021	1

510(k) clearances on record, most recent first
K number	Device	Product code	Decision	Decision date
K210225	Surgical Face Mask	FXX	Substantially Equivalent	2021-03-04

Registered establishments

No FDA establishment registrations recorded against this company.

FDA product codes

FXXMask, Surgical

Recall records

Device recall records naming this company, most recent first
Recall	Product	Reason	Classification	Initiated	Status
Z-3308-2024	DVOT SARS-CoV-2 & RSV &MP &ADV & FIu A/B Antigen Combo Test Kit, Model Number ACT01	The "DVOT brand" rapid test kits have not obtained the necessary authorization to be sold in the United States.	Class II	2024-06-26	Open, Classified
Z-3307-2024	DVOT SARS-Cov-2 &Influenza A+B Antigen Combo Test Kit, Model Number FAT01	The "DVOT brand" rapid test kits have not obtained the necessary authorization to be sold in the United States.	Class II	2024-06-26	Open, Classified
Z-3306-2024	DVOT SARS-CoV-2 ANTIGEN TEST KIT, Model Number FCY-AGT-01	The "DVOT brand" rapid test kits have not obtained the necessary authorization to be sold in the United States.	Class II	2024-06-26	Open, Classified

Verification record

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Data as of 2026-09-28, FDA export datePage updated 2026-09-05Source: openFDA, public domain