Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3014601569

FEI Number

3014601569

Entity Name

SKG Health Technologies Co., LTD

City/State/Country

Shen Zhen City Guangdong, CN

Establishment 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 518000, CN

Establishment Type(s)

Manufacture Medical Device,Manufacture Medical Device for Another Party (Contract Manufacturer),Foreign Private Label Distributor

Owner / Operator

SKG Health Technologies Co., LTD (Owner Number: 10083283)

Owner / Operator Contact Address

23A Floor,Building 3,Zhongke R & D Park,No. 009, Gaoxin South 1st Road,High-tech Zone Community,Yuehai str She, Shen Zhen City, CN-GD 518000, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Neck Massager:G7 Pro-Fold Smart Neck Stimulator;K5-3EN Smart Neck Stimulator;G7ProE Smart Neck Stimulator;K6E Smart Neck Stimulator;4356E Smart Neck Stimulator;4098E Smart Neck Stimulator; 4098 (RED) Smart Neck Stimulator;K5pro Massager Neck Tens;1014706 Neck Massager:G7 Pro-E Neck Massager:G7Pro-Max Neck Massager:GS500-N Neck Massager:G7Pro Fold;G7Pro_Fold Neck Massager:K5-3Pro SKG Blood Pressure Monitor SKG Bluetooth Blood Pressure Monitor Body Massager :F7-E;F5-EN;F3 LITE; Leg Massager;S1719HB Mini Body Massager :F3-EN; Knee Massager:W3 Pro,WS500; Eye massager:E7-EN;E3 Pro;ES300;ES500; Neck and shoulder massager:H5 Mini;H7 Max ;H7 Ultra ;H7 Ultra E;HS500-2;G7Pro_Fold Massage Gun:X7-E; Back & Neck Massager:T1-2Pro; Waist Massager:W9Ultra;W9Pro Foot Massager: YS100 SKG THERAPY DEVIC Knee Massager: WS500 Neck Massager:G7 Pro-Fold Neck Massager:GS500-N Waist Massager:W9Ultra

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NUH	Stimulator, Nerve, Transcutaneous, Over-The-Counter	Neurology	Class 2	882.5890	2021-11-08
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2025-12-09
ISA	Massager, Therapeutic, Electric	Physical Medicine	Class 1	890.5660	2022-03-01
ILY	Lamp, Infrared, Therapeutic Heating	Physical Medicine	Class 2	890.5500	2025-08-21

Official Correspondent

ZHIMIN LIN

US Agent Details

Mike Ryan Business: Simply Shipped, LLC Email: simplyshipped.agent@gmail.com Phone: (414) 3264114

Related Public Records

Same Entity

SKG Health Technologies Co., LTD

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K100940	Andon Health Co, Ltd.	FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-5965	2010-06-29
K251581	Shenzhen Hingmed Medical Instrument Co., Ltd.	Wearable Ambulatory Blood Pressure Monitor (WBP-02A)	2026-02-13
K200521	Health & Life Co., Ltd.	Full Automatic(NIBP) Blood Pressure Monitor	2020-06-12
K152003	Andon Health Co, Ltd.	iHealth BP3L Wireless Blood Pressure Monitor	2015-09-24
K952827	Sein Electronics Co., Ltd.	FULL AUTO WRIST BLOOD PRESSURE METER MODEL SE-5000	1996-11-14

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0032-2025	MEDLINE INDUSTRIES, LP Northfield	2	MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT, REF MDS1001
Z-0033-2025	MEDLINE INDUSTRIES, LP Northfield	2	MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT, REF MDS1001U.
Z-0034-2025	MEDLINE INDUSTRIES, LP Northfield	2	MEDLINE Automatic Digital Blood Pressure Monitor, REF MDS1001UT.

Similar Registrations

Registration Number	Establishment Name	Location
3029924973	SHENZHEN SINREL TECH LTD	Shenzhen Guangdong, CN
3003255790	WITKO INCORPORATED	Wolcott, IN, US
3038295706	JUST KEEP HEALTHY CO., LTD.	Samkkei Munichay District Kampong Speu, KH
3011562129	MIRAE MEDI&TECH CO., LTD.	Cheonan-si Chungnam, KR
3005170249	Shenzhen Dongdixin Technology Co., Ltd.	SHENZHEN Guangdong, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014601569. Last updated year: 2026. Please use registration number 3014601569 when referencing this establishment in official correspondence.