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SKG Health Technologies Co., LTD: FDA-registered device maker in Shen Zhen City Guangdong, China, 2 510(k) clearances

Name: SKG Health Technologies Co., LTD FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

SKG Health Technologies Co., LTD is registered with the FDA (registration 3014601569) in Shen Zhen City Guangdong, China. It lists 5 device types. The FDA files 2 510(k) clearances under its listings, the newest dated August 2, 2024. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3014601569
Address: 23A Floor,Building 3,Zhongke R & D Park,No. 009, Gaoxin South 1st Road,High-tech Zone Community,Yuehai str, Shen Zhen City Guangdong, China, 518000
Owner or operator: SKG Health Technologies Co., LTD (10083283)
Roles: Contract manufacturer, Foreign private label distributor, Manufacturer, Repackager or relabeler
First device listed: November 8, 2021
Registered through: 2026
Brand names listed: Back & Neck Massager:T1-2Pro;, Body Massager :F7-E;F5-EN;F3 LITE;, Eye massager:E7-EN;E3 Pro;ES300;ES500;, Foot Massager: YS100, Knee Massager: WS500, Knee Massager:W3 Pro,WS500;, Leg Massager;S1719HB, Massage Gun:X7-E; and more

Devices it lists

Device	Product code	Class	Role	Source
Lamp, Infrared, Therapeutic Heating	ILY	2	Contract manufacturer, Foreign private label distributor, Manufacturer	accessdata.fda.gov
Massager, Powered Inflatable Tube	IRP	2	Foreign private label distributor, Repackager or relabeler	accessdata.fda.gov
Massager, Therapeutic, Electric	ISA	1	Contract manufacturer, Foreign private label distributor, Manufacturer	accessdata.fda.gov
Stimulator, Nerve, Transcutaneous, Over-The-Counter	NUH	2	Foreign private label distributor, Manufacturer	accessdata.fda.gov
System, Measurement, Blood-Pressure, Non-Invasive	DXN	2	Foreign private label distributor	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 2, 2024	K240981	Air compression leg massager	IRP	Substantially Equivalent	Huizhou Xinyi Technology Co., Ltd.	accessdata.fda.gov
October 4, 2021	K200558	Smart Neck Stimulator	NUH	Substantially Equivalent	Guandong Skg Intelligent Technology Co., Ltd.	accessdata.fda.gov

Compare with other makers

Updated August 2, 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.