Ellex
Fgoods, Wheelchair Accessible, Mobile
12manufacturers in China registered for this device type
5catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (5), Shanghai (3), Beijing (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| 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 |
| Beijing Hongdee Corporation | Beijing | Beijing | Private-label distributor | 43 |
| 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 Link Instruments Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 21 |
| Gino Optical (Shanghai) Co., Ltd. | Shanghai | Shanghai | Manufacturer | 15 |
| Shanghai Canton Optics Equipment Co., Ltd. | Shanghai | Shanghai | Manufacturer | 14 |
| Shanghai Mediworks Precision Instruments Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 13 |
| Jiangsu Liangxu Intelligence Science AND Technology Co., Ltd. | Nanjing | Jiangsu | Contract manufacturer | 12 |
| Ningbo Ming Sing Optical R&D Co., Ltd. | Ningbo | Zhejiang | Repacker / relabeller | 9 |
| Langfang FAR East Prosperous Optical Instrument Co., Ltd. | Langfang | Hebei | Contract manufacturer | 5 |
Record
| Listed by | Ellex Medical Pty Ltd, Australia |
|---|---|
| FDA product code | HRJ |
| Device type | Table, Instrument, Powered, Ophthalmic |
| Device class | Class 1 |
| Regulation | 21 CFR 886.4855 |
| Establishment | Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2023-06-09 |
| Record revised | 2024-12-11 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| TS_ACCESS-MOBILE | In distribution | |
| COLUMN_LV | In distribution | |
| TS_ACCESS | In distribution | |
| COLUMN_HV | In distribution | |
| TS_MOBILE | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Ophthalmic Electric Table | MDT SP. Z O.O. | 20 |
| S4 Optik | Innova Medical Ophthalmics | 7 |
| Tiannuo / Tnmed | Lianyungang Tiannuo Optical Instrument Co., Ltd. | 6 |
| IDS-300 | Topcon Corp. | 4 |
| Motorized Instrument Table | Lightmed Corp. | 3 |
| AIT-250W | Topcon Corp. | 3 |
| Ophthalmic unit | Ningbo Ming Sing Optical R&D Co., Ltd. | 3 |
| System Table | Nidek Incorporated | 3 |
| Evans (Instruments) Limited | Evans (Instruments) Limited | 2 |
| AIT-16A | Topcon Corp. | 2 |
| AIT-350W | Topcon Corp. | 2 |
| S4Optik | Innova Medical Ophthalmics | 2 |
Showing 12 of 54. All products under Table, Instrument, Powered, Ophthalmic
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.