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Devon Medical Products (jiangsu) Ltd: FDA-registered device maker in Nantong Jiangsu, China, 14 510(k) clearances

Name: Devon Medical Products (jiangsu) Ltd FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Devon Medical Products (jiangsu) Ltd is registered with the FDA (registration 3009538657) in Nantong Jiangsu, China. It lists 12 device types. The FDA files 14 510(k) clearances under its listings, the newest dated March 19, 2019. Registered through 2026. FDA data exported November 3, 2026.

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FDA registration number: 3009538657
Address: No.8 Tongxing Road,Economic & Technological Development Area, Nantong Jiangsu, China, 226009
Owner or operator: Devon Medical Products (Jiangsu) Ltd (10053567)
Roles: Manufacturer, Repackager or relabeler
First device listed: December 16, 2016
Registered through: 2026
Brand names listed: Compression Socks, Devon 24D, Devon 24R Deep Vein Thrombosis (DVT) Prevention Therapy System, Devon 52, Devon 62, Foam Kit, Gel Strip, Negative pressure wound therapy canisters and more

Devices it lists

Device	Product code	Class	Role	Source
Joint, Knee, External Brace	ITQ	1	Repackager or relabeler	accessdata.fda.gov
Negative Pressure Wound Therapy Powered Suction Pump	OMP	2	Manufacturer	accessdata.fda.gov
Pad, Heating, Powered	IRT	2	Repackager or relabeler	accessdata.fda.gov
Sleeve, Limb, Compressible	JOW	2	Manufacturer	accessdata.fda.gov
Stimulator, Electrical, Transcutaneous, For Arthritis	NYN	2	Repackager or relabeler	accessdata.fda.gov
Stimulator, Muscle, Powered	IPF	2	Repackager or relabeler	accessdata.fda.gov
Stimulator, Muscle, Powered, For Muscle Conditioning	NGX	2	Repackager or relabeler	accessdata.fda.gov
Stimulator, Nerve, Transcutaneous, For Pain Relief	GZJ	2	Repackager or relabeler	accessdata.fda.gov
Stimulator, Nerve, Transcutaneous, Over-The-Counter	NUH	2	Repackager or relabeler	accessdata.fda.gov
Stimulator, Neuromuscular, External Functional	GZI	2	Repackager or relabeler	accessdata.fda.gov
Stocking, Medical Support (For General Medical Purposes)	FQL	1	Repackager or relabeler	accessdata.fda.gov
Stocking, Medical Support (To Prevent Pooling Of Blood In Legs)	DWL	2	Repackager or relabeler	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
March 19, 2019	K190423	Devon 24D Deep Vein Thrombosis (DVT) Prevention Therapy System	JOW	Substantially Equivalent	Devon Medical Products (Jiangsu), Ltd.	accessdata.fda.gov
March 14, 2019	K182203	JKH Stimulator Plus	NUH	Substantially Equivalent	Jkh USA, LLC	accessdata.fda.gov
February 21, 2019	K182578	Devon 62 Deep Vein Thrombosis (DVT) Prevention Therapy Device	JOW	Substantially Equivalent	Devon Medical Products (Jiangsu), Ltd.	accessdata.fda.gov
December 18, 2018	K182150	Devon 52 Sequential Compression Device	JOW	Substantially Equivalent	Devon Medical Products (Jiangsu), Ltd.	accessdata.fda.gov
February 6, 2018	K173528	Devon 24R Deep Vein Thrombosis (DVT) Prevention Therapy System	JOW	Substantially Equivalent	Devon Medical Products (Jiangsu), Ltd.	accessdata.fda.gov
November 27, 2017	K172030	Devon 51	JOW	Substantially Equivalent	Devon Medical Products (Jiangsu), Ltd.	accessdata.fda.gov
June 9, 2015	K151240	extriCARE Negative Pressure Wound Therapy Gel Strip - 8pc, extriCARE Negative Pressure Wound Therapy Gel Strip - 7pc, extriCARE Negative Pressure Wound Therapy Gel Strip - 6pc, extriCARE Negative Pressure Wound Therapy Gel Strip - 5pc, extriCARE Negative Pressure Wound Therapy Gel Strip - 4pc	OMP	Substantially Equivalent	Devon Medical Products	accessdata.fda.gov
February 3, 2015	K143362	extriCARE 3600 Negative Pressure Wound Therapy System 1000cc canister	OMP	Substantially Equivalent	Devon Medical Products	accessdata.fda.gov
September 19, 2014	K140634	extriCARE 2400 NPWT System with extriCARE 2400 NPWT Pump and extriCARE NPWT Foam Dressing Kit	OMP	Substantially Equivalent	Devon Medical, Inc.	accessdata.fda.gov
June 27, 2014	K141578	DEVON CIRONA 6200 DVT	JOW	Substantially Equivalent	Devon Medical	accessdata.fda.gov
May 15, 2014	K132225	EXTRICARE	OMP	Substantially Equivalent	Devon Medical, Inc.	accessdata.fda.gov
September 27, 2013	K132252	EXTRICARE 100CC/ 250CC/ 400CC CANISTERS	OMP	Substantially Equivalent	Devon Medical	accessdata.fda.gov
August 13, 2013	K131464	EXTRICARE NPWT FOOT DRESSING	OMP	Substantially Equivalent	Devon Medical, Inc.	accessdata.fda.gov
February 10, 2012	K110078	EXTRICARE	OMP	Substantially Equivalent	Devon Medical Products, Inc.	accessdata.fda.gov

Compare with other makers

Updated March 19, 2019. 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.