Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3033435469

FEI Number

3033435469

Entity Name

OGAWA WELLNESS VIETNAM COMPANY LIMITED

City/State/Country

Long An, VN

Establishment Address

Factory B2-11, Lot A6-2, A7, A8, A17-1, A18, A19-2, Doc 2 Road, Phu An Thanh Ben Luc Commune , Tay Ninh ,Vietnam, Long An 850000, VN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

OGAWA WELLNESS VIETNAM COMPANY LIMITED (Owner Number: 10091627)

Owner / Operator Contact Address

Factory B1-5, Lot A6-2, A7, A8, A17-1, A18, A19-2, Doc 2 Street, Phu An Thanh Industrial Park,, An Thanh Commune, Ben Luc District, Long An,Viet Nam, Long An, VN-NOTA 850000, VN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Shark Depuffi Shark FacialPro Glow Beauty face mask Shark Depuffi Shark FacialPro Glow SHARPER IMAGE:1021577,1021578, Neck and Shoulder Wrap

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IRT	Pad, Heating, Powered	Physical Medicine	Class 2	890.5740	2024-10-20
IME	Pack, Hot Or Cold, Reusable	Physical Medicine	Class 1	890.5700	2025-04-22
ISA	Massager, Therapeutic, Electric	Physical Medicine	Class 1	890.5660	2025-04-22
IRP	Massager, Powered Inflatable Tube	Physical Medicine	Class 2	890.5650	2025-04-23
IRP	Massager, Powered Inflatable Tube	Physical Medicine	Class 2	890.5650	2025-12-31

Official Correspondent

zhen wu

US Agent Details

Clare Ho Business: SHARE INFO INC. Email: cfrhealthcare@foxmail.com Phone: (929) 4102964

Related Public Records

Same Entity

OGAWA WELLNESS VIETNAM COMPANY LIMITED

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K881862	Thermo Body Wrap Systems, Inc.	THERMO-BODY-WRAP SYSTEM	1988-10-13
K242140	Jiale Health Technology Shenzhen Co., Ltd.	Air Compression Leg Massager (K-705)	2025-03-17

Similar Registrations

Registration Number	Establishment Name	Location
3014113673	DONGGUAN XINJIN THERMO CONTROL MANUFACTURING CO., LTD.	DONGGUAN CITY Guangdong, CN
3042277608	LIAONING DIKANGYUAN HEALTH TECHNOLOGY CO.,LTD.	LIAOYANG Liaoning, CN
3013284090	SHENZHEN H&T INTELLIGENT CONTROL CO., LTD.	Shenzhen Guangdong, CN
3014290933	Wuhu OWFine Electronic Technology Co., Ltd.	Wuhu Anhui, CN
3026312365	BEIJING ETERNAL MEDICAL TECHNOLOGY CO.,LTD.	Beijing, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3033435469. Last updated year: 2026. Please use registration number 3033435469 when referencing this establishment in official correspondence.