Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005157379

FEI Number

3005157379

Entity Name

JIANGSU REAK HEALTHY ARTICLES CO.,LTD

City/State/Country

Yangzhong City Jiangsu, CN

Establishment Address

No.1 Jiangzhou Square, Yangzhong City Jiangsu 212200, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Jiangsu Reak Healthy Articles Co.,Ltd (Owner Number: 9072998)

Owner / Operator Contact Address

No.1 Jiangzhou Square, Yangzhong City, CN-JS 212200, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

ORTHOSIS, TRUNCAL/ORTHOSIS, LIMB BODY SUPPORT Armboard MELANGE BRACES AND LIMP SUPPORT SPLINT, HAND, AND COMPONENTS MELANGE BRACES AND LIMP SUPPORTS Protector, skin pressure MELANGE BRACES AND LIMP SUPPORTS Dressing adaptor JOINT, KNEE, EXTERNAL BRACE MELANGE BRACES AND LIMP SUPPORTS Crutch, Grip & Underarm pillow

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IQE	Orthosis, Lumbar	Physical Medicine	Class 1	890.3490	2017-01-07
KTD	Orthosis, Abdominal	Physical Medicine	Class 1	890.3490	2017-01-07
MRI	Orthosis, Truncal/Orthosis, Limb	Physical Medicine	Class 1	890.3490	2007-06-12
CCX	Support, Patient Position	Anesthesiology	Class 1	868.6820	2017-03-21
ITS	Joint, Hip, External Brace	Physical Medicine	Class 1	890.3475	2005-05-11
ILH	Splint, Hand, And Components	Physical Medicine	Class 1	890.3475	2005-05-11
FMP	Protector, Skin Pressure	General Hospital	Class 1	880.6450	2025-06-26
IQI	Orthosis, Limb Brace	Physical Medicine	Class 1	890.3475	2018-06-12
IOY	Support, Arm	Physical Medicine	Class 1	890.3475	2005-05-11
ILD	Adaptor, Dressing	Physical Medicine	Class 1	890.5050	2015-12-16
ITQ	Joint, Knee, External Brace	Physical Medicine	Class 1	890.3475	2005-05-11
INP	Tips And Pads, Cane, Crutch And Walker	Physical Medicine	Class 1	890.3790	2017-12-18

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

Jiangsu Reak Healthy Articles Co.,Ltd

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 3005157379. Last updated year: 2026. Please use registration number 3005157379 when referencing this establishment in official correspondence.