Data / Medical devices / Vietnam / Hameco Hy Co., Ltd

Hameco Hy Co., Ltd: FDA-registered device maker in Hung Yen Province, Vietnam, 4 510(k) clearances

Name: Hameco Hy Co., Ltd FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Hameco Hy Co., Ltd is registered with the FDA (registration 3006400320) in Hung Yen Province, Vietnam. It lists 31 device types. The FDA files 4 510(k) clearances under its listings, the newest dated January 14, 1983. Registered through 2026. FDA data exported November 2, 2026.

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Get makers like this one Watch Hameco Hy Co., Ltd

FDA registration number: 3006400320
Address: Chi Trung Hamlet, Nhu Quynh Commune, Hung Yen Province, Vietnam, 17000
Owner or operator: HAMECO., JSC (9096901)
Roles: Contract manufacturer, Exporter to the US, Manufacturer
First device listed: January 22, 2007
Registered through: 2026
Brand names listed: ANKLE BRACE, Ankle Support, Armboard Strap, Back support with suspenders max soos 3, Binder, Medical, Therapeutic, CIRCUMSTRAINT BOARD STRAPS, CPM Pads, CUSHION,WHEELCHAIR, GEL FOAM CUSHION and more

Devices it lists

Device	Product code	Class	Role	Source
Accessories, Wheelchair	KNO	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Adaptor, Hygiene	ILS	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Aid, Transfer	IKX	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Band Or Belt, Pelvic Support	ISR	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Bandage, Elastic	FQM	1	Manufacturer	accessdata.fda.gov
Bedding, Disposable, Medical	KME	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Binder, Medical, Therapeutic	MDR	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Components, Exercise	IOD	1	Manufacturer	accessdata.fda.gov
Cushion, Wheelchair	IMP	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Exerciser, Powered	BXB	1	Manufacturer	accessdata.fda.gov
Gauze / Sponge,Nonresorbable For External Use	NAB	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Gown, Examination	FME	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Joint, Ankle, External Brace	ITW	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Joint, Knee, External Brace	ITQ	1	Contract manufacturer, Exporter to the US	accessdata.fda.gov
Non-Surgical Gown	OEA	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Orthosis, Abdominal	KTD	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Orthosis, Cervical	IQK	1	Manufacturer	accessdata.fda.gov
Orthosis, Limb Brace	IQI	1	Contract manufacturer, Exporter to the US	accessdata.fda.gov
Orthosis, Lumbar	IQE	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Orthosis, Truncal/Orthosis, Limb	MRI	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Pack, Hot Or Cold, Reusable	IME	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Pediatric Position Holder	PRN	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Protector, Skin Pressure	FMP	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Restraint, Protective	FMQ	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Sling, Arm	ILI	1	Exporter to the US, Manufacturer	accessdata.fda.gov
Splint, Hand, And Components	ILH	1	Contract manufacturer, Exporter to the US	accessdata.fda.gov
Stirrup, External Brace Component	ITC	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Support, Hernia	EXN	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Support, Patient Position	CCX	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Tape, Measuring, Rulers And Calipers	FTY	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Tips And Pads, Cane, Crutch And Walker	INP	1	Contract manufacturer, 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
January 14, 1983	K823808	VARIOUS ARM SLING	ILI	Substantially Equivalent	Danek Medical, Inc.	accessdata.fda.gov
December 30, 1982	K823666	UNIVERSAL WRIST SPLINT & FOREARM SPLINT	ILH	Substantially Equivalent	Warm & Form, Orthopedic Materials	accessdata.fda.gov
March 4, 1981	K810443	LIMB ORTHOSIS	IQI	Substantially Equivalent	Fred Sammons, Inc.	accessdata.fda.gov
November 12, 1980	K802673	KNEE BRACE/STABILIZER	ITQ	Substantially Equivalent	Omni Scientific, Inc.	accessdata.fda.gov

Compare with other makers

Updated January 14, 1983. 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.