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Shenzhen Yicai Health Technology Co., Ltd: FDA-registered device maker in Shenzhen Guangdong, China, 3 510(k) clearances

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

Shenzhen Yicai Health Technology Co., Ltd is registered with the FDA (registration 3018109879) in Shenzhen Guangdong, China. It lists 10 device types. The FDA files 3 510(k) clearances under its listings, the newest dated September 17, 2025. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3018109879
Address: 11th floor, Zhenqian Building, Yousong Community, Longhua Street, Longhua District, Shenzhen Guangdong, China, 518110
Owner or operator: Shenzhen Yicai Health Technology Co., Ltd (10080936)
Roles: Contract manufacturer, Exporter to the US, Manufacturer
First device listed: March 8, 2021
Registered through: 2026
Brand names listed: Bluetooth Eye Mask, Cold Flow Machine, Electric Heating Pad, Electric hot pad, Energy Mood Light, Eye Heat Massager, Eye Mask with White Noise, Eye Masks and more

Devices it lists

Device	Product code	Class	Role	Source
Dispenser, Solid Medication	NXB	1	Contract manufacturer, Exporter to the US, Manufacturer	accessdata.fda.gov
Lamp, Infrared, Therapeutic Heating	ILY	2	Contract manufacturer, Exporter to the US, Manufacturer	accessdata.fda.gov
Massager, Powered Inflatable Tube	IRP	2	Manufacturer	accessdata.fda.gov
Pack, Hot Or Cold, Disposable	IMD	1	Contract manufacturer, Exporter to the US, Manufacturer	accessdata.fda.gov
Pack, Hot Or Cold, Reusable	IME	1	Contract manufacturer, Exporter to the US, Manufacturer	accessdata.fda.gov
Pack, Hot Or Cold, Water Circulating	ILO	2	Manufacturer	accessdata.fda.gov
Pad, Heating, Powered	IRT	2	Contract manufacturer, Exporter to the US, Manufacturer	accessdata.fda.gov
Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)	HOY	1	Contract manufacturer, Exporter to the US, Manufacturer	accessdata.fda.gov
Stimulator, Muscle, Powered, For Muscle Conditioning	NGX	2	Manufacturer	accessdata.fda.gov
Stimulator, Nerve, Transcutaneous, Over-The-Counter	NUH	2	Manufacturer	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
September 17, 2025	K251623	Air Compression Therapy Device (K1002/K1006/K1007/K1008/K1061)	IRP	Substantially Equivalent	Shenzhen Yicai Health Technology Co., Ltd.	accessdata.fda.gov
August 21, 2025	K250784	Transcutaneous Electrical Nerve Stimulator ( K6133/ K6134/ K6135/ K6136/ K6137/ K6138/ K6139/ K6140/ K6141/ K6142/ K6143/ K6144/ K6122)	NUH	Substantially Equivalent	Shenzhen Yicai Health Technology Co., Ltd.	accessdata.fda.gov
July 22, 2024	K241119	Transcutaneous Electrical Nerve Stimulator (K6106)	NUH	Substantially Equivalent	Shenzhen Yicai Health Technology Co., Ltd.	accessdata.fda.gov

Compare with other makers

Updated September 17, 2025. 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.