Data / Medical devices / Chair, Ophthalmic, Ac-Powered

Chair, Ophthalmic, Ac-Powered (HME): 25 FDA-registered makers in 12 countries

Name: FDA-registered makers of Chair, Ophthalmic, Ac-Powered
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

25 establishments in 12 countries are registered with the FDA to make Chair, Ophthalmic, Ac-Powered (product code HME, Class 1, 21 CFR 886.1140). 0 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 16 510(k) clearances under this code, the latest on July 6, 1993, and lists 1 recall event (0 Class I). FDA data exported November 2, 2026.

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Product code: HME
Device class: 1
Regulation: 886.1140
Medical specialty: Ophthalmic

Makers by country

Country	Makers
United States	6
India	5
China	4
Japan	2
Spain	1
Brazil	1
Canada	1
Italy	1
Taiwan	1
Poland	1
Lithuania	1
Germany	1

Makers of Chair, Ophthalmic, Ac-Powered

Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.

Maker	Location	Role	Recall events	Source
Akriti Ophthalmic Private Limited	Hyderabad Telangana, India	Manufacturer	0	api.fda.gov
Antoni Carles, S.A.	VILASSAR DE MAR Barcelona, Spain	Contract manufacturer, Exporter to the US, Manufacturer	0	api.fda.gov
Appasamy Associates Private Limited ( Ambattur)	Chennai Tamil Nadu, India	Manufacturer	0	api.fda.gov
Apramed Industria E Comercio De Aparelhos Medicos Ltda	SAO CARLOS Sao Paulo, Brazil	Manufacturer	0	api.fda.gov
Apramed USA LLC	Kissimmee, FL, United States	Manufacturer, Repackager or relabeler	0	api.fda.gov
Blue.s4	Belleville Ontario, Canada	Manufacturer	0	api.fda.gov
C.S.O. S.R.L.	Scandicci Firenze, Italy	Manufacturer	0	api.fda.gov
Dexta Corp.	Napa, CA, United States	Manufacturer	0	api.fda.gov
Haag-Streit Usa, Inc.	Mason, OH, United States	Manufacturer	0	api.fda.gov
Hanson & Zollinger Inc	Berlin, NJ, United States	Contract manufacturer	0	api.fda.gov
Kuang Yeu Medical Co., Ltd.	Taichung City, TAIWAN, Taiwan	Manufacturer	0	api.fda.gov
Lianyungang Tiannuo Optical Instrument Co., Ltd.	LIANYUNGANG Jiangsu, China	Contract manufacturer, Repackager or relabeler	0	api.fda.gov
M/S Tarun Enterprises	Prayagraj, Uttar Pradesh, India	Manufacturer	0	api.fda.gov
MDT SP. Z O.O.	KRAKOW Malopolskie, Poland	Manufacturer	0	api.fda.gov
Medinstrus UAB	MAZEIKIU R Mazeikiai, Lithuania	Contract manufacturer, Manufacturer, Repackager or relabeler	0	api.fda.gov
Myvision Medical Pvt. Ltd.	Ahmedabad Gujarat, India	Manufacturer	0	api.fda.gov
Ray Vision Inc.	Lake Forest, CA, United States	Repackager or relabeler, Specification developer	0	api.fda.gov
Shanghai Canton Optics Equipment Co., Ltd.	Shanghai, China	Exporter to the US, Manufacturer	0	api.fda.gov
Speedway	India Delhi, India	Manufacturer	0	api.fda.gov
Takagi Seiko Co., Ltd.	NAKANO-SHI Nagano, Japan	Exporter to the US, Manufacturer	0	api.fda.gov
Towa Medical Instruments Co.,ltd.	Nakano-shi Nagano, Japan	Contract manufacturer, Manufacturer	0	api.fda.gov
Taiyuan North China Xinyuan Tech. Center (Co., LTD.)	TAIYUAN Shaanxi, China	Contract manufacturer, Manufacturer	0	api.fda.gov
Topcon Healthcare, Inc.	Oakland, NJ, United States	Specification developer	0	api.fda.gov
Ufsk-International Osys GMBH	REGENSBURG Bavaria, Germany	Exporter to the US, Manufacturer	1	api.fda.gov
Wuxi Zontai Int'l Corporation Ltd.	WUXI Jiangsu, China	Contract manufacturer, Exporter to the US, Manufacturer	0	api.fda.gov

Updated July 6, 1993. 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.