Ufsk-Osys Treatment Chair

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

Registry build 21.09.26
6manufacturers in China registered for this device type
4catalogue numbers in this listing
1recall

Who Else Makes It

Concentrated in Jiangsu (4), Shanghai (1), Shaanxi (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code HME
Manufacturer City Province Registered as Device types
Wuxi Zontai Int’l Corporation Ltd. Wuxi Jiangsu Contract manufacturer 22
Taiyuan North China Xinyuan Tech. Center (Co., Ltd.) Taiyuan Shaanxi Contract manufacturer 14
Taizhou City K&W International Trade Co., Ltd. Jiangyan Jiangsu Repacker / relabeller 38
Lianyungang Tiannuo Optical Instrument Co., Ltd. Lianyungang Jiangsu Contract manufacturer 31
Shanghai Canton Optics Equipment Co., Ltd. Shanghai Shanghai Manufacturer 14
Visuscience Meditech Co., Ltd. Wuxi Jiangsu Specification developer 9

Record

Regulatory record for Ufsk-Osys Treatment chair
Listed by Ufsk-International Osys Gmbh, Germany
FDA product code HME
Device type Chair, Ophthalmic, Ac-Powered
Device class Class 1
Regulation 21 CFR 886.1140
Establishment Manufacturer, Exporter
Premarket notification Exempt
Record published 2026-03-02

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Label carries manufacturing date, serial number
Distribution end date 2027-01-01

Catalogue Numbers

Catalogue numbers for Ufsk-Osys Treatment chair
Catalogue number Size Status
500 ECO In distribution
500 XLS In distribution
500 XLE In distribution
eyeForce In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
OC-2200 Topcon Corp. 105
OC-2300 Topcon Corp. 52
OC-2400 Topcon Corp. 21
S4 Optik Innova Medical Ophthalmics 15
Reliance Haag-Streit USA, Inc. 15
Ufsk-Osys Surgeon’s chair Ufsk-International Osys Gmbh 8
Marco Takagi Seiko Co., Ltd. 6
Topcon Antoni Carles SA 4
Lombart Innova Medical Ophthalmics 2
Marco Innova Medical Ophthalmics 2
Illuminix Illuminix Industries LLC 1
Surgical Table MDT SP. Z O.O. 1

Showing 12 of 14. All products under Chair, Ophthalmic, Ac-Powered

Recalls

1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.

Recalls referencing this product code
Initiated FDA class Root cause Reason Quantity
2023-05-31 Class II Device Design Service life of the electrical seat part drive of the treatment chair may be shortened unexpectedly after several years of use due to a potential wear-related reduction in the self-locking of the drive and may remain undetected. A worsened 239 chairs US

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

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