Chair, Ophthalmic, Ac-Powered

Who Makes This Device Type in China?

Chinese manufacturers registered for this device type are concentrated in Jiangsu, Shaanxi and Shanghai: 6 hold an FDA registration. 2 are contract manufacturers.

Lianyungang Tiannuo Optical Instrument Co., Ltd. Jiangsu, contract manufacturer
Shanghai Canton Optics Equipment Co., Ltd. Shanghai
Taizhou City K&W International Trade Co., Ltd. Jiangsu
Taiyuan North China Xinyuan Tech. Center (Co., Ltd.) Shaanxi, contract manufacturer
Visuscience Meditech Co., Ltd. Jiangsu
Wuxi Zontai Int'l Corporation Ltd. Jiangsu, contract manufacturer

What Is FDA Product Code HME?

Chair, Ophthalmic, Ac-Powered is FDA product code HME, Class 1, 21 CFR 886.1140.

What Does It Take to Sell It in the United States?

It is exempt from premarket notification: the manufacturer registers its establishment and lists the device, and no 510(k) is needed before it is sold in the United States.

What Do the Recalls Say?

The FDA has recorded 1 recall under this product code since 2023. None was by a company in China. The root cause the FDA records most often is Device Design (1).

A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.

Chair, Ophthalmic, Ac-Powered

Ophthalmic Operator’s Chair

Catalogue number OC-1, listed by MDT SP. Z O.O., Poland, under Chair, Ophthalmic, Ac-Powered. 6 manufacturers in China are registered for this product code.

Chair, Ophthalmic, Ac-Powered

Luxvision

Ophthalmic Refraction unit RU-1000

Chair, Ophthalmic, Ac-Powered

Marco

Marco e-tilt Chair - Model ETILT-CH-H-M

Chair, Ophthalmic, Ac-Powered

Surgical Table

Catalogue number SC-1, listed by MDT SP. Z O.O., Poland, under Chair, Ophthalmic, Ac-Powered. 6 manufacturers in China are registered for this product code.

Chair, Ophthalmic, Ac-Powered

Illuminix

Chair with motorized elevation and reclining for patient still seated for eye refraction examination

Chair, Ophthalmic, Ac-Powered

Topcon

IS-100 Ophthalmic Chair Model OC-8 Dark Grey

Chair, Ophthalmic, Ac-Powered

Ufsk-Osys Surgeon’s Chair

Surgeon's chair for positioning of the surgeon for microsurgical treatments, with adjustable arm rests

Chair, Ophthalmic, Ac-Powered

Ufsk-Osys Treatment Chair

Treatment chair for positioning and support of the patient for outpatient microsurgical treatments in ophthalmology, ENT and dental surgery

Chair, Ophthalmic, Ac-Powered

Lombart

Lombart CS6 Chair - Model CS-6-CH-H-CHAR

Chair, Ophthalmic, Ac-Powered

OC-2400

OC-2400 CHAIR - COLONIAL BLUE 110/120 VOLT LOW; Ophthalmic examination chair

Chair, Ophthalmic, Ac-Powered

Reliance

15 catalogue numbers from FXM920 Chair, listed by Haag-Streit USA, Inc., United States, under Chair, Ophthalmic, Ac-Powered. 6 manufacturers in China are registered for this product code.

Chair, Ophthalmic, Ac-Powered

Marco

6 catalogue numbers from MARCO TILT CHAIR, listed by Takagi Seiko Co., Ltd., Japan, under Chair, Ophthalmic, Ac-Powered. 6 manufacturers in China are registered for this product code.

Chair, Ophthalmic, Ac-Powered

OC-2300

OC-2300 CHAIR-SPECL 120 VOLT HIGH NO UPHOLSTERY; Ophthalmic examination chair

Chair, Ophthalmic, Ac-Powered

OC-2200

OC-2200 CHAIR-COFFEE CREAM 110/120 VOLT HIGH; Ophthalmic examination chair

Chair, Ophthalmic, Ac-Powered

S4 Optik

S4OPTIK Ophthalmic Examination Chair - Model 2000-CH-H-FIX

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China

2,581device types they are registered for

340,248device records, each naming its maker

31provinces with a registered manufacturer