Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013553519

FEI Number

3013553519

Entity Name

DAITO HEALTHCARE APPLIANCES(TAICANG) CO., LTD.

City/State/Country

taicang Jiangsu, CN

Establishment Address

20 Fengnan road, Shuangfeng,, taicang Jiangsu 215416, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer),Manufacture Medical Device

Owner / Operator

OSIM International Pte Ltd (Owner Number: 10086683)

Owner / Operator Contact Address

20 Fengnan road, Shuangfeng,, taicang, CN-JS 215416, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

OS-8201 uThrone OS-8215 uThrone V OS-290S uJolly 2 Smart

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ISA	Massager, Therapeutic, Electric	Physical Medicine	Class 1	890.5660	2022-12-01

Official Correspondent

Christina Cheong

US Agent Details

Alan Cheng Email: alan@osim.com Phone: (757) 2240177

Related Public Records

Same Entity

OSIM International Pte Ltd

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

View Entity Profile →

Similar Registrations

Registration Number	Establishment Name	Location
3016460723	ZHEJIANG AOLIN INDUSTRY & TRADE CO., LTD.	Lishui Zhejiang, CN
3032903908	TECHDERM LLC	Palm Beach Gardens, FL, US
3030407739	CL MEDIX INC	Chantilly, VA, US
3009079475	Aerotel Ltd.	Holon Central, IL
3025350087	LENYO WORLD LTD	Budapest, HU

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013553519. Last updated year: 2026. Please use registration number 3013553519 when referencing this establishment in official correspondence.