Table, Examination, Medical, Powered
FDA product code LGX · Class I (low risk) · 21 CFR 878.4960 · General, Plastic Surgery
14510(k) clearances
0PMA approvals
15recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K945163 | EchocardiographyLGX · Traditional | Tri W-G, Inc. | 02/17/1995SE |
| K894144 | Power Examination Table Model # 405LGX · Traditional | Midmark Corp. | 08/28/1989SE |
| K894134 | Power Examination Table Model # 411LGX · Traditional | Midmark Corp. | 08/28/1989SE |
| K883680 | Medalist Examination TableLGX · Traditional | Hamilton Industries, Inc. | 10/04/1988SE |
| K882010 | Power Examination TableLGX · Traditional | Enochs Mfg., Inc. | 07/13/1988SE |
| K864072 | Adec 1005-C ChairLGX · Traditional | Cherne Industries, Inc. | 11/07/1986SE |
| K860519 | Reliance Model 200 Podiatry ChairLGX · Traditional | F. & F. Koenigkramer | 02/19/1986SE |
| K845023 | Storz Plastic Surgery & Examination Lounge 7000LGX · Traditional | Storz Instrument Co. | 01/28/1985SE |
| K830294 | Medical Exam TableLGX · Traditional | Coe Laboratories, Inc. | 01/11/1984SE |
| K832768 | S & W SW52E W/Power Back LiftLGX · Traditional | S & W Enterprises, Inc. | 09/20/1983SE |
| K820823 | Multiple, Model #17LGX · Traditional | Midmark Corp. | 04/21/1982SE |
| K811623 | SMR Paragon Chair TableLGX · Traditional | Smr | 07/02/1981SE |
| K811190 | Three Models of Tables, Stools, & LightsLGX · Traditional | Midmark Corp. | 05/08/1981SE |
| K810900 | Castle Procedure and Ritter Exam. TablesLGX · Traditional | Sybron Corp. | 04/21/1981SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0730-2024 Class II | Ultrasound EA (Ergonomic Advantage) table version; V2 (Vascular 2 Section)…Backrest platform stress fracture - the table is not operational in an inclined position | Oakworks Inc | 12/05/2023Open, Classified |
| Z-0729-2024 Class II | Ultrasound EA (Ergonomic Advantage) table versions; G3 Multi-Specialty Echocardiography…Backrest platform stress fracture - the table is not operational in an inclined position | Oakworks Inc | 12/05/2023Open, Classified |
| Z-0728-2024 Class II | Ultrasound EA (Ergonomic Advantage) table versions; G3 (General 3 Section)…Backrest platform stress fracture - the table is not operational in an inclined position | Oakworks Inc | 12/05/2023Open, Classified |
| Z-0727-2024 Class II | Ultrasound EA (Ergonomic Advantage) table versions; G2 (GENERAL 2) -An Ultrasound…Backrest platform stress fracture - the table is not operational in an inclined position | Oakworks Inc | 12/05/2023Open, Classified |
| Z-2349-2021 Class II | Vascular Table without Fowler (USV1) and Ultrasound Vascular Table with Fowler (USV2).…Weld failure- the bracket attaches the tabletop tilting actuator to the tabletop frame. If the bracket weld… | Oakworks Inc | 06/29/2021Terminated |
| Z-1734-2019 Class II | GETINGE MEERA MOBILE OPERATING TABLE: (1) Part 720001B2 (2) Part 720001B0 (3) Part…User may suffer an electric shock when coming in contact with the exposed electronic components | Maquet Cardiovascular Us Sales, Llc | 05/06/2019Terminated |
| Z-2531-2018 Class II | Access Hi-Low Exam Tables, Model 6501-XXOne lot, the wire harness was over-crimped on some of the connectors that go to the two vertical side… | Brewer Company, LLC | 03/29/2018Terminated |
| Z-0353-2020 Class II | 2000 Vascular with 30 Degree optionPotential for bed to drop suddenly at the head while a patient is laying on it. | Heritage Medical Products, Inc. | 09/02/2016Terminated |
| Z-2211-2014 Class II | Medical Positioning Rapid Response HUT table, Powered Medical Examination table, Model #…Excessive weight on the table will cause tables with the affected component to drop into the Trendelenburg… | Medical Positioning Inc | 07/10/2014Terminated |
| Z-2210-2014 Class II | Medical Positioning Rapid Response HUT table with Dual 2 Way Drop Section, Powered…Excessive weight on the table will cause tables with the affected component to drop into the Trendelenburg… | Medical Positioning Inc | 07/10/2014Terminated |
| Z-2209-2014 Class II | Medical Positioning Rapid Response HUT table, Powered Medical Examination table, Model #…Excessive weight on the table will cause tables with the affected component to drop into the Trendelenburg… | Medical Positioning Inc | 07/10/2014Terminated |
| Z-2208-2014 Class II | Medical Positioning Rapid Response HUT table, Powered Medical Examination table, Model #…Excessive weight on the table will cause tables with the affected component to drop into the Trendelenburg… | Medical Positioning Inc | 07/10/2014Terminated |
| Z-1622-2013 Class II | MAQUET Getinge Group Mobile Operating Table YUNO OTN GA 1433.01 EN 05. The YUNO OTN is…MAQUET has identified a potential issue with the extension device handle (part number 1433.62A1) and will… | Maquet Cardiovascular Us Sales, Llc | 04/26/2013Terminated |
| Z-1211-2012 | MPI Rapid Response HUT Table, Model #RRHUT 1017. The firm name on the label is Medical…The warning label regarding electrical shock was not placed on the device warning to have the power switch… | Medical Positioning Inc | 03/05/2012Terminated |
| Z-1210-2012 | MPI Rapid Response HUT Table, Model #RRHUT 1217 with Dual 2 Way Drop Section. The firm…The warning label regarding electrical shock was not placed on the device warning to have the power switch… | Medical Positioning Inc | 03/05/2012Terminated |