Data / Medical devices / Vietnam / Ogawa Wellness Vietnam Company Limited

Ogawa Wellness Vietnam Company Limited: FDA-registered device maker in Long An, Vietnam, 1 510(k) clearance

Name: Ogawa Wellness Vietnam Company Limited FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Ogawa Wellness Vietnam Company Limited is registered with the FDA (registration 3033435469) in Long An, Vietnam. It lists 6 device types. The FDA files 1 510(k) clearance under its listings, the newest dated June 9, 2023. Registered through 2026. FDA data exported November 3, 2026.

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FDA registration number: 3033435469
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, Vietnam, 850000
Owner or operator: OGAWA WELLNESS VIETNAM COMPANY LIMITED (10091627)
Roles: Contract manufacturer, Exporter to the US, Manufacturer
First device listed: October 20, 2024
Registered through: 2026
Brand names listed: Beauty face mask, SHARPER IMAGE:1021577,1021578, Neck and Shoulder Wrap, Shark Depuffi, Shark FacialPro Glow

Devices it lists

Device	Product code	Class	Role	Source
Light Based Over The Counter Wrinkle Reduction	OHS	2	Manufacturer	accessdata.fda.gov
Massager, Powered Inflatable Tube	IRP	2	Contract manufacturer	accessdata.fda.gov
Massager, Therapeutic, Electric	ISA	1	Contract manufacturer, Exporter to the US, Manufacturer	accessdata.fda.gov
Over-The-Counter Powered Light Based Laser For Acne	OLP	2	Manufacturer	accessdata.fda.gov
Pack, Hot Or Cold, Reusable	IME	1	Contract manufacturer, Exporter to the US, Manufacturer	accessdata.fda.gov
Pad, Heating, Powered	IRT	2	Contract manufacturer, Exporter to the US, Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
June 9, 2023	K230293	TheraFace Mask	OHS	Substantially Equivalent	Therabody, Inc.	accessdata.fda.gov

Compare with other makers

Updated June 9, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.