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Shenzhen Wap-Health Technology Co., Ltd.: FDA-registered device maker in Shenzhen Guangdong, China, 2 510(k) clearances

Name: Shenzhen Wap-Health Technology Co., Ltd. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Shenzhen Wap-Health Technology Co., Ltd. is registered with the FDA (registration 3011647251) in Shenzhen Guangdong, China. It lists 16 device types. The FDA files 2 510(k) clearances under its listings, the newest dated August 11, 2023. Registered through 2026. FDA data exported November 3, 2026.

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FDA registration number: 3011647251
Address: Floor 3, Building C, The Third Industrial Zone #23, Gongming Guangming New District, Shenzhen Guangdong, China, 518106
Owner or operator: Shenzhen WAP-health Technology Co., Ltd. (10060544)
Roles: Manufacturer, Repackager or relabeler
First device listed: May 23, 2019
Registered through: 2026
Brand names listed: Bandage, Cabinet, Hearing aid, Splint, Valve, WAP-health

Devices it lists

Device	Product code	Class	Role	Source
Bandage, Cast	ITG	1	Repackager or relabeler	accessdata.fda.gov
Bandage, Elastic	FQM	1	Repackager or relabeler	accessdata.fda.gov
Cabinet, Instrument, Ac-Powered, Ophthalmic	HRE	1	Manufacturer	accessdata.fda.gov
Cabinet, Table And Tray, Anesthesia	BRY	1	Manufacturer	accessdata.fda.gov
Cpr Aid Device Without Feedback	PMK	1	Repackager or relabeler	accessdata.fda.gov
Dressing, Wound, Hydrophilic	NAC	1	Repackager or relabeler	accessdata.fda.gov
First Aid Kit Without Drug	OHO	1	Repackager or relabeler	accessdata.fda.gov
Gauze / Sponge,Nonresorbable For External Use	NAB	1	Repackager or relabeler	accessdata.fda.gov
Hearing Aid, Group And Auditory Trainer	EPF	2	Repackager or relabeler	accessdata.fda.gov
Kit, First Aid, Talking	OVR	1	Repackager or relabeler	accessdata.fda.gov
Mask, Oxygen	BYG	1	Repackager or relabeler	accessdata.fda.gov
Mouthpiece, Breathing	BYP	1	Repackager or relabeler	accessdata.fda.gov
Polymer Patient Examination Glove	LZA	1	Repackager or relabeler	accessdata.fda.gov
Scissors, Medical, Disposable	JOK	1	Repackager or relabeler	accessdata.fda.gov
Splint, Temporary Training	IQM	1	Repackager or relabeler	accessdata.fda.gov
Valve, Non-Rebreathing	CBP	2	Repackager or relabeler	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
August 11, 2023	K231408	Basic Synguard Nitrile Exam Gloves, Powder Free, Blue Colored, Non-Sterile	LZA	Substantially Equivalent	Shandong Intco Medical Products Co, Ltd.	accessdata.fda.gov
November 17, 2017	K171961	Compower CPR Mask With Oxygen Port, Compower CPR Mask Without Oxygen Port, Compower Infant CPR Mask, Compower Non-Rebreathing Valve (22mm/15mmOD), Non-Rebreathing Valve (22mm/18.5mm)	CBP	Substantially Equivalent	Xiamen Compower Medical Tech. Co., Ltd.	accessdata.fda.gov

Compare with other makers

Updated August 11, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.