Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006400320

FEI Number

3006400320

Entity Name

HAMECO HY CO., LTD

City/State/Country

HUNG YEN PROVINCE, VN

Establishment Address

CHI TRUNG HAMLET, NHU QUYNH COMMUNE, HUNG YEN PROVINCE 17000, VN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer),Manufacture Medical Device

Owner / Operator

HAMECO., JSC (Owner Number: 9096901)

Owner / Operator Contact Address

17 Pho Duc Chinh Str., Ba Dinh Dist., HA NOI, VN-NOTA 100000, VN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Back support with suspenders max soos 3 Disposable Armboard Cover CIRCUMSTRAINT BOARD STRAPS Crutch Pillow PILLOW,COMFORT PLUS ELBOW AND FOOT,PR LIFTER,LEG,BLACK,40" Packs Binder, Medical, Therapeutic Hernia belt SHOULDER IMMOBILIZER Ankle Support ORBE Finger Sleeves CUSHION,WHEELCHAIR, GEL FOAM CUSHION Stirrup Strap KNEE IMMOBILIZER Examination Gown cpm pad LIMB ORTHOSIS RIB BELT ANKLE BRACE CPM Pads Maternity belt ORBE Surgical Sponge Sticks

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IQE	Orthosis, Lumbar	Physical Medicine	Class 1	890.3490	2022-01-07
KME	Bedding, Disposable, Medical	General Hospital	Class 1	880.6060	2023-03-22
PRN	Pediatric Position Holder	General Hospital	Class 1	880.5680	2024-11-22
INP	Tips And Pads, Cane, Crutch And Walker	Physical Medicine	Class 1	890.3790	2021-02-25
FMP	Protector, Skin Pressure	General Hospital	Class 1	880.6450	2026-06-12
IKX	Aid, Transfer	Physical Medicine	Class 1	890.5050	2018-02-01
IME	Pack, Hot Or Cold, Reusable	Physical Medicine	Class 1	890.5700	2022-12-02
MDR	Binder, Medical, Therapeutic	General Hospital	Class 1	880.5160	2023-04-24
EXN	Support, Hernia	Gastroenterology, Urology	Class 1	876.5970	2022-01-07
ILI	Sling, Arm	Physical Medicine	Class 1	890.3640	2007-01-22
ITW	Joint, Ankle, External Brace	Physical Medicine	Class 1	890.3475	2021-03-11
MRI	Orthosis, Truncal/Orthosis, Limb	Physical Medicine	Class 1	890.3490	2013-08-08
FQM	Bandage, Elastic	General Hospital	Class 1	880.5075	2020-08-05
KNO	Accessories, Wheelchair	Physical Medicine	Class 1	890.3910	2025-09-18
ITC	Stirrup, External Brace Component	Physical Medicine	Class 1	890.3410	2022-03-29
ITQ	Joint, Knee, External Brace	Physical Medicine	Class 1	890.3475	2007-01-22
FME	Gown, Examination	General Hospital	Class 1	880.6265	2020-10-28
BXB	Exerciser, Powered	Physical Medicine	Class 1	890.5380	2013-08-09
IQI	Orthosis, Limb Brace	Physical Medicine	Class 1	890.3475	2007-01-22
ISR	Band Or Belt, Pelvic Support	Physical Medicine	Class 1	890.3025	2022-01-07
IOD	Components, Exercise	Physical Medicine	Class 1	890.5350	2015-02-20
NAB	Gauze / Sponge,Nonresorbable For External Use	General, Plastic Surgery	Class 1	878.4014	2023-06-05

Official Correspondent

LE TAT CO

US Agent Details

Gerry Van Wagner Email: gvanwagner@rivalusa.com Phone: (623) 2821002

Related Public Records

Same Entity

HAMECO., JSC

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

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006400320. Last updated year: 2026. Please use registration number 3006400320 when referencing this establishment in official correspondence.