Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3034205725

FEI Number

3034205725

Entity Name

REAK VIETNAM COMPANY LIMITED

City/State/Country

Nhon Trach Commune Dong Nai, VN

Establishment Address

No. A2-1.F2, Road No. D3, Nhon Trach II - Loc Khang Industrial Park, Nhon Trach Commune Dong Nai 815920, VN

Establishment Type(s)

Manufacture Medical Device,Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

REAK VIETNAM COMPANY LIMITED (Owner Number: 10092253)

Owner / Operator Contact Address

No. A2-1.F2, Road No. D3, Nhon Trach II - Loc Khang Industrial Park, Nhon Trach Commune, VN-39 815920, VN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

SUPPORT, ARM Pack, hot or cold, reusable Sleeve, Limb, Compressible SPLINT, HAND, AND COMPONENTS JOINT, KNEE, EXTERNAL BRACE ORTHOSIS, ABDOMINAL ORTHOSIS, LUMBAR ORTHOSIS, TRUNCAL/ORTHOSIS, LIMB

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IOY	Support, Arm	Physical Medicine	Class 1	890.3475	2024-12-17
IME	Pack, Hot Or Cold, Reusable	Physical Medicine	Class 1	890.5700	2024-12-17
JOW	Sleeve, Limb, Compressible	Cardiovascular	Class 2	870.5800	2026-02-11
ILH	Splint, Hand, And Components	Physical Medicine	Class 1	890.3475	2024-12-17
ITQ	Joint, Knee, External Brace	Physical Medicine	Class 1	890.3475	2024-12-17
KTD	Orthosis, Abdominal	Physical Medicine	Class 1	890.3490	2024-12-17
IQE	Orthosis, Lumbar	Physical Medicine	Class 1	890.3490	2024-12-17
MRI	Orthosis, Truncal/Orthosis, Limb	Physical Medicine	Class 1	890.3490	2024-12-17

Official Correspondent

No official correspondent registered.

US Agent Details

Jay Mansour Business: Mansour Consulting LLC Email: jay@mansourconsulting.com Phone: (678) 9088180

Related Public Records

Same Entity

REAK VIETNAM COMPANY LIMITED

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
K170216	Tactile Systems Technology, Inc. (Dba Tactile Medical)	Flexitouch System	2017-05-26
K100306	Covidien	KENDALL SCD SEQUENTIAL COMPRESSION COMFORT SLEEVES	2010-05-04

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3007207474	BARBARAS DEVELOPMENT, INC.	Thousand Oaks, CA, US
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3034205725. Last updated year: 2026. Please use registration number 3034205725 when referencing this establishment in official correspondence.