Flex Access Exam Table
12 catalogue numbers from 5700, listed by The Brewer Company LLC, United States, under Table, Examination, Medical, Powered. 11 manufacturers in China are registered for this product code.
11manufacturers in China registered for this device type
12catalogue numbers in this listing
1recall
Who Else Makes It
Concentrated in Jiangsu (3), Zhejiang (2), Guangdong (2).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zhejiang Mediunion Healthcare Group Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 105 |
| Ningbo Ningyuan Import & Export Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 80 |
| Jiangsu Yongfa Medical Equipment Technology Co., Ltd. | Zhangjiagang | Jiangsu | Manufacturer | 33 |
| Jiangsu Sintang Health&Technology Co., Ltd. | Yancheng | Jiangsu | Manufacturer | 21 |
| Foshan Suncare Medical Products Co Ltd | Foshan | Guangdong | Contract manufacturer | 20 |
| Hebei Jiede Medical Equipment Co., Ltd. | Hengshui | Hebei | Contract manufacturer | 20 |
| Hengshui Shuntai Kangyuan Medical Equipment Co., Ltd. | Hengshui | Hebei | Manufacturer | 11 |
| Kanghui Medical Technology (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 11 |
| Huangshan Jinfu Medical Equipment Co., Ltd. | Huangshan | Anhui | Manufacturer | 7 |
| Shanghai PAX Medical Instrument Co., Ltd. | Shanghai | Shanghai | Manufacturer | 7 |
| Caretek(China) Medical PLC | Guangzhou | Guangdong | Manufacturer | 6 |
Record
| Listed by | The Brewer Company LLC, United States |
|---|---|
| FDA product code | LGX |
| Device type | Table, Examination, Medical, Powered |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4960 |
| Establishment | Contract manufacturer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2022-12-05 |
| Record revised | 2023-11-28 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Over the counter | Yes |
| Label carries | lot or batch number, serial number |
| Distribution end date | 2025-11-10 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 5700 | In distribution | |
| 5801 | In distribution | |
| 5800 | In distribution | |
| 5701 | In distribution | |
| 5800 | Withdrawn | |
| 5700 | Withdrawn | |
| 5800 | Withdrawn | |
| 5801 | Withdrawn | |
| 5801 | Withdrawn | |
| 5701 | Withdrawn | |
| 5700 | Withdrawn | |
| 5701 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Intensa | GF Health Products, Inc | 521 |
| Hausted | GF Health Products, Inc | 363 |
| Oakworks Medical | Oakworks, Inc. | 97 |
| Medstone | Stille AB | 33 |
| Reison | Stille AB | 32 |
| Enochs Examining Room Furniture | Enochs Manufacturing Inc | 23 |
| Armboard | Reison Medical AB | 16 |
| Access High-Low Table | The Brewer Company LLC | 15 |
| Access HLT Plus Exam Table | The Brewer Company LLC | 12 |
| EchoTable | Medical Positioning, Inc. | 9 |
| Armboard turnable | Reison Medical AB | 9 |
| UltraScan Versa | Medical Positioning, Inc. | 8 |
Showing 12 of 83. All products under Table, Examination, Medical, 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.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2018-03-29 | Class II | Nonconforming Material/Component | One lot, the wire harness was over-crimped on some of the connectors that go to the two vertical side switches on the exam table. | 7 devices | 2019-08-29 |
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.