Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3021987422

FEI Number

3021987422

Entity Name

ORIHEALTH MEDICAL PRODUCTS(SUZHOU)CO.,LTD

City/State/Country

Suzhou Jiangsu, CN

Establishment Address

No.7 Xinmiao RD,New District,Taicang, Suzhou Jiangsu 215400, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

ORIHEALTH Medical Products(Suzhou)Co.,Ltd (Owner Number: 10084426)

Owner / Operator Contact Address

No.7 Xinmiao RD,New District,Taicang, Suzhou, CN-JS 215400, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

IM-PAL 10-1262 STS Groin Strap with Pad 10-1264 STS ankle strap with fixed cup TRAUMA CAP: 10-2020 STS Slishman Traction Splint: PRE-10-0262 STS-C Compact Traction Splint: PRE-10-0270

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GCZ	Retainer, Surgical	General, Plastic Surgery	Class 1	878.4800	2023-09-11
FQM	Bandage, Elastic	General Hospital	Class 1	880.5075	2023-08-21
HSP	Splint, Traction	Orthopedic	Class 1	888.5890	2022-02-20

Official Correspondent

Ann Xu

US Agent Details

FANFEI LIU Email: U.S.agent@frosatechnology.com Phone: (626) 8261385

Related Public Records

Same Entity

ORIHEALTH Medical Products(Suzhou)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 3021987422. Last updated year: 2026. Please use registration number 3021987422 when referencing this establishment in official correspondence.