RR HUT Table
RR HUT Table No Drop, Memory, Rails
11manufacturers in China registered for this device type
4catalogue numbers in this listing
6recalls 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 | Medical Positioning, 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 | 2020-08-20 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1058 | In distribution | |
| 1258 | In distribution | |
| 1056 | In distribution | |
| 1256 | In distribution |
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
4 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 |
|---|---|---|---|---|---|
| 2014-07-10 | Class II | Component design/selection | Excessive weight on the table will cause tables with the affected component to drop into the Trendelenburg position more rapidly than normal. The product was manufactured with a component that can cause the device to malfunction. | 2 beds | 2017-01-03 |
| 2014-07-10 | Class II | Component design/selection | Excessive weight on the table will cause tables with the affected component to drop into the Trendelenburg position more rapidly than normal. The product was manufactured with a component that can cause the device to malfunction. | 20 beds | 2017-01-03 |
| 2014-07-10 | Class II | Component design/selection | Excessive weight on the table will cause tables with the affected component to drop into the Trendelenburg position more rapidly than normal. The product was manufactured with a component that can cause the device to malfunction. | 1 bed | 2017-01-03 |
| 2014-07-10 | Class II | Component design/selection | Excessive weight on the table will cause tables with the affected component to drop into the Trendelenburg position more rapidly than normal. The product was manufactured with a component that can cause the device to malfunction. | 17 beds | 2017-01-03 |
| 2012-03-05 | Not classified | Error in labeling | The warning label regarding electrical shock was not placed on the device warning to have the power switch in the “OFF” position prior to connecting the unit to electric power. | 4 tables | 2013-07-11 |
| 2012-03-05 | Not classified | Error in labeling | The warning label regarding electrical shock was not placed on the device warning to have the power switch in the “OFF” position prior to connecting the unit to electric power. | 5 tables | 2013-07-11 |
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.