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Zhangzhou Easepal Medical Science And Technology Co.,ltd.: FDA-registered device maker in zhangzhou Fujian, China, 1 510(k) clearance

Name: Zhangzhou Easepal Medical Science And Technology Co.,ltd. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Zhangzhou Easepal Medical Science And Technology Co.,ltd. is registered with the FDA (registration 3014386328) in zhangzhou Fujian, China. It lists 8 device types. The FDA files 1 510(k) clearance under its listings, the newest dated September 17, 2024. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3014386328
Address: Room 401,No.7 Building,No. 228 Jiaosong Road,Jiaomei Town,Zhangzhou Taiwanese Investment Zone, zhangzhou Fujian, China, 363100
Owner or operator: Zhangzhou Easepal Medical Science And Technology Co.,Ltd. (10084572)
Roles: Contract manufacturer, Exporter to the US, Manufacturer
First device listed: March 27, 2023
Registered through: 2026
Brand names listed: Air Compression Leg Massager (Model: MM0520, MM0521, MM0522), CryoGlow, CryoGlow Plus, IPL Salon Hair Reduction System, Redlight & Infrared LEDs, Shark Depuffi, Shark FacialPro Glow

Devices it lists

Device	Product code	Class	Role	Source
Lamp, Infrared, Therapeutic Heating	ILY	2	Exporter to the US, Manufacturer	accessdata.fda.gov
Light Based Over The Counter Wrinkle Reduction	OHS	2	Contract manufacturer	accessdata.fda.gov
Light Based Over-The-Counter Hair Removal	OHT	2	Contract manufacturer	accessdata.fda.gov
Massager, Powered Inflatable Tube	IRP	2	Manufacturer	accessdata.fda.gov
Over-The-Counter Powered Light Based Laser For Acne	OLP	2	Contract manufacturer	accessdata.fda.gov
Pack, Hot Or Cold, Reusable	IME	1	Contract 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

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, 2024	K240373	Air compression Leg Massager (MM0520, MM0521, MM0522)	IRP	Substantially Equivalent	Zhangzhou Easepal Medical Science and Technology Co., Ltd.	accessdata.fda.gov

Compare with other makers

Updated September 17, 2024. 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.