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Zhangzhou Easepal Innovation Co.,ltd: FDA-registered device maker in Zhangzhou Fujian, China, 2 510(k) clearances

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

Zhangzhou Easepal Innovation Co.,ltd is registered with the FDA (registration 3017103444) in Zhangzhou Fujian, China. It lists 7 device types. The FDA files 2 510(k) clearances under its listings, the newest dated June 9, 2023. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3017103444
Address: No36.Longkun Road, Hongjian Village, Jiaomei Town, Zhangzhou Taiwanese Investment Zone, Zhangzhou Fujian, China, 363107
Owner or operator: Zhangzhou Easepal Innovation Co.,Ltd (10069598)
Roles: Contract manufacturer, Manufacturer
First device listed: April 25, 2020
Registered through: 2026
Brand names listed: Carepeutic: KH265-V02, Carepeutic:Carepeutic Massagers, Carshion: C245103.C245104 Heated Seat Cushion: C245101 Heated Seat Cover, EP-1129, Eye Massager:LF-ME001-TPK,LF-ME001-TWT,LS-ME001-JPK, FED Fitness Air Compression Boots;EP-1129, Foot Massager:LFF001-OSCO, HP-G42AJ Hot & Cold Gel Eye Mask and more

Devices it lists

Device	Product code	Class	Role	Source
Lamp, Infrared, Therapeutic Heating	ILY	2	Manufacturer	accessdata.fda.gov
Light Based Over The Counter Wrinkle Reduction	OHS	2	Manufacturer	accessdata.fda.gov
Massager, Powered Inflatable Tube	IRP	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Massager, Therapeutic, Electric	ISA	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Over-The-Counter Powered Light Based Laser For Acne	OLP	2	Manufacturer	accessdata.fda.gov
Pack, Hot Or Cold, Reusable	IME	1	Manufacturer	accessdata.fda.gov
Pad, Heating, Powered	IRT	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
June 9, 2023	K230293	TheraFace Mask	OHS	Substantially Equivalent	Therabody, Inc.	accessdata.fda.gov
March 14, 2023	K223464	Leg and Foot Air Wave Pressure Therapy Device	IRP	Substantially Equivalent	Zhangzhou Easepal Innovation CO , Ltd.	accessdata.fda.gov

Compare with other makers

Updated June 9, 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.