Data / Medical devices / China / Dongguan Quanding Medical Supplies Co., Ltd

Dongguan Quanding Medical Supplies Co., Ltd: FDA-registered device maker in Dongguan Guangdong, China, 3 510(k) clearances

Name: Dongguan Quanding Medical Supplies Co., Ltd FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Dongguan Quanding Medical Supplies Co., Ltd is registered with the FDA (registration 3017450375) in Dongguan Guangdong, China. It lists 14 device types. The FDA files 3 510(k) clearances under its listings, the newest dated September 25, 2024. Registered through 2026. FDA data exported November 3, 2026.

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FDA registration number: 3017450375
Address: 3 Yongfa East Road, Qishi Town, Dongguan Guangdong, China, 523500
Owner or operator: Dongguan Quanding Medical Supplies Co., Ltd (10075777)
Roles: Contract manufacturer, Manufacturer, Repackager or relabeler
First device listed: March 17, 2021
Registered through: 2026
Brand names listed: 07,QD-TM008,CB8000,CB8001,CB8002,CB8003,CB8004,CB8005,CB8006,CB8007,CB8008,QD-SN101,QD-SN102,QD-SN103,QD-SN104,QD-SN105,, Adhesive Electrode pads, CB-FS07,CB-FS08,CB-FS09,CB-FS10,CB-FS11,CB-FS12,CB-FS13,CB-FS14;CB-FS15., CB-TB03,CB-TB04,CB-TB05,CB-TB06., CT01,CT02,CT03,CT04,CT05,CT06,CT07,CT08;HCT01,HCT02,HCT03,HCT04,HCT05,HCT06,HCT07,HCT08, Chilling unit QD-CH201,QD-CH202,QD-CH203,QD-CH204,QD-CH205,QD-CH301,QD-CH302,QD-CH303,QD-CH304,QD-CH305, Disposable ECG Electrode ECG301,ECG302, ECG303, ECG304, ECG305, ECG306, ECG307, ECG308, ECG309, ECG310, Disposable Neutral Electrodes : GP201B-A, GP202B-A, GP202B-P, GP202B-I, GP202M-A, GP202M-P, GP202M-I, GP202B-AC, and more

Devices it lists

Device	Product code	Class	Role	Source
Bandage, Elastic	FQM	1	Manufacturer	accessdata.fda.gov
Cable, Electrode	IKD	2	Manufacturer	accessdata.fda.gov
Electrode, Cutaneous	GXY	2	Manufacturer	accessdata.fda.gov
Electrode, Electrocardiograph	DRX	2	Manufacturer	accessdata.fda.gov
Electrosurgical, Cutting & Coagulation & Accessories	GEI	2	Manufacturer	accessdata.fda.gov
Irrigator, Powered Nasal	KMA	1	Manufacturer	accessdata.fda.gov
Massager, Therapeutic, Electric	ISA	1	Manufacturer	accessdata.fda.gov
Pad, Heating, Powered	IRT	2	Manufacturer	accessdata.fda.gov
Set, Tubing And Support, Ventilator (W Harness)	BZO	1	Manufacturer	accessdata.fda.gov
Stimulator, Muscle, Powered	IPF	2	Repackager or relabeler	accessdata.fda.gov
Stimulator, Muscle, Powered, For Muscle Conditioning	NGX	2	Contract manufacturer, Repackager or relabeler	accessdata.fda.gov
Stimulator, Nerve, Transcutaneous, Over-The-Counter	NUH	2	Contract manufacturer, Repackager or relabeler	accessdata.fda.gov
Unit, Chilling	IMF	1	Manufacturer	accessdata.fda.gov
Unit, Heating, Powered	IRQ	1	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 25, 2024	K242204	Disposable Neutral Electrodes (GP201B-A, GP202B-A, GP202B-P, GP202B-I, GP202M-A, GP202M-P, GP202M-I, GP202B-AC, GP202B-PC, GP202B-IC, GP202M-AC, GP202M-PC, GP202M-IC, GP203M-A, GP203B-A, GP203M-AC, GP203B-AC, GP203M-P, GP203B-P, GP203M-PC, GP203B-PC, GP203M-I, GP203B-I, GP203M-IC, GP203B-IC)	GEI	Substantially Equivalent	Dongguan Quanding Medical Supplies Co., Ltd.	accessdata.fda.gov
May 6, 2022	K213788	TENS&EMS STIMULATOR (Model: KRES100D, KRES1010, KRES1020, KRES1080)	NUH	Substantially Equivalent	Dongguan Bohuikang Technology Co.,Ltd	accessdata.fda.gov
December 13, 2017	K171381	Adhesive Electrodes	GXY	Substantially Equivalent	Shenzhen Quality Medical Technology Co.,Ltd	accessdata.fda.gov

Compare with other makers

Updated September 25, 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.