Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008175569

FEI Number

3008175569

Entity Name

ROSHUNG INTERNATIONAL CO, LIMITED

City/State/Country

Qingdao Shandong, CN

Establishment Address

NO.619 International Business Center, NO 196 Zhengyang Rd. Chengyang, Qingdao Shandong 266000, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

RoShung International Co, Limited (Owner Number: 10046651)

Owner / Operator Contact Address

NO.619 International Business Center, NO 196 Zhengyang Rd. Chengyang, Qingdao, CN-SD 266000, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Doctor In The House Miracle Splint DITH neck free shoulder system Miracle Back DITH neck free shoulder system

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ITW	Joint, Ankle, External Brace	Physical Medicine	Class 1	890.3475	2019-12-08
ILH	Splint, Hand, And Components	Physical Medicine	Class 1	890.3475	2014-04-22
MRI	Orthosis, Truncal/Orthosis, Limb	Physical Medicine	Class 1	890.3490	2017-10-09
IQI	Orthosis, Limb Brace	Physical Medicine	Class 1	890.3475	2014-04-22

Official Correspondent

MK Park

US Agent Details

Laura Fried Business: Doctor In the House Inc Email: lfried26@gmail.com Phone: (610) 2771998

Related Public Records

Same Entity

RoShung International Co, Limited

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 3008175569. Last updated year: 2026. Please use registration number 3008175569 when referencing this establishment in official correspondence.