PCG Series
100 Procedure Chair 3 Section Top; 27" Width; 240V Electric
11manufacturers in China registered for this device type
1catalogue number
5recalls on this code
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 | Oakworks, Inc., United States |
|---|---|
| FDA product code | LGX |
| Device type | Table, Examination, Medical, Powered |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4960 |
| Establishment | Manufacturer |
| Premarket notification | Exempt |
| Record published | 2023-08-12 |
| Record revised | 2025-01-01 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | manufacturing date, serial number |
| Distribution end date | 2024-12-31 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 100 Procedure Chair / PCG Chair | Withdrawn |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 |
| Flex Access Exam Table | The Brewer Company LLC | 12 |
| Access HLT Plus Exam Table | The Brewer Company LLC | 12 |
| EchoTable | Medical Positioning, Inc. | 9 |
| Armboard turnable | Reison Medical AB | 9 |
Showing 12 of 83. All products under Table, Examination, Medical, Powered
Recalls
5 of these are 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 |
|---|---|---|---|---|---|
| 2023-12-05 | Class II | Device Design | Backrest platform stress fracture – the table is not operational in an inclined position | 28 units | |
| 2023-12-05 | Class II | Device Design | Backrest platform stress fracture – the table is not operational in an inclined position | 104 units | |
| 2023-12-05 | Class II | Device Design | Backrest platform stress fracture – the table is not operational in an inclined position | 212 units | |
| 2023-12-05 | Class II | Device Design | Backrest platform stress fracture – the table is not operational in an inclined position | 20 units | |
| 2021-06-29 | Class II | Process control | Weld failure- the bracket attaches the tabletop tilting actuator to the tabletop frame. If the bracket weld fails, the tabletop tilting action is non-functional | 55 units | 2023-10-05 |
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.