Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3030175335

FEI Number

3030175335

Entity Name

RUITAI OUTDOOR EQUIPMENT CO., LTD

City/State/Country

PHU DUC COMMUNE Hung Yen, VN

Establishment Address

MR. Nguyen Dinh Quans House, To Ho Village, PHU DUC COMMUNE Hung Yen none, VN

Establishment Type(s)

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

Owner / Operator

RUITAI OUTDOOR EQUIPMENT CO., LTD (Owner Number: 10089165)

Owner / Operator Contact Address

MR. NGUYEN DINH QUAN'S HOUSE, TO HO VILLAGE, PHU DUC COMMUNE, VN-66 none, VN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Shoulder Abduction Sling: 59015, Shoulder Immobilizer:59025 WALKER-10002,10003,10005,10007,10008,10002RED,10003RED,10005RED, 10007RED,10008RED,10002BLU,10003BLU,10005BLU,10007BLU, 11008,11102,11103,11105,11107,11108,11002RED,11003RED,11005RED,11007RED,11008RED,11002BLU,11003BLU,11005BLU,11005BLU,11007BLU11008BLU 10008BLK,10102,10103, 10105, 10107, 10108, 10102RED,10103RED, 10105RED,10107RED,10108RED,10102BLU 10103BLU,10105BLU,10107BLU, 10108BLU,10102BLK,10103BLK,10105BLK,10107BLK,10108BLK,11002,11003,11005,11007

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IOY	Support, Arm	Physical Medicine	Class 1	890.3475	2025-04-25
IQI	Orthosis, Limb Brace	Physical Medicine	Class 1	890.3475	2023-11-09

Official Correspondent

No official correspondent registered.

US Agent Details

David Lennarz Business: Registrar Corp. Email: david.lennarz@registrarcorp.com Phone: (757) 2240177

Related Public Records

Same Entity

RUITAI OUTDOOR EQUIPMENT CO., LTD

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

View Entity Profile →

Similar Registrations

Registration Number	Establishment Name	Location
3043730244	DALIAN WACOAL CO., LTD.	Dalian Economic and Technological Development Zone Liaoning, CN
3010508273	LIANG CHENG SPORTING GOODS COMPANY LIMITED	Ben Cat Town Binh Duong, VN
1649518	Sterigenics US LLC	Fort Worth, TX, US
3007207474	BARBARAS DEVELOPMENT, INC.	Thousand Oaks, CA, US
3017619379	Jiangsu Juneng Sports Goods Technology Co., Ltd	Yangzhou Jiangsu, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3030175335. Last updated year: 2026. Please use registration number 3030175335 when referencing this establishment in official correspondence.