Skytron
Keylock for premium drawer requires PD-XX (N= 1 or 2 Keys)(V= key style 1 all different, 2 all same, 3 left + right key = identical; but different from other drawers, 4 left + right key =…
Keylock for premium drawer requires PD-XX (N= 1 or 2 Keys)(V= key style 1 all different, 2 all same, 3 left + right key = identical; but different from other drawers, 4 left + right key = different; but identical sets for other drawers
11manufacturers in China registered for this device type
200catalogue numbers in this listing
7recalls on this code
Who Else Makes It
Concentrated in Jiangsu (6), Shanghai (1), Anhui (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Jiangsu Saikang Medical Equipment Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 34 |
| Jiangsu Yongfa Medical Equipment Technology Co., Ltd. | Zhangjiagang | Jiangsu | Manufacturer | 33 |
| Shanghai NO. 2 Medical College Duhang Medical Equipment Factory | Shanghai | Shanghai | Contract manufacturer | 32 |
| Jiangsu Rooe Medical Technology Co., Ltd. | Zhangjiagang | Jiangsu | Manufacturer | 31 |
| Hefei MT Medical Co., Ltd. | Hefei | Anhui | Manufacturer | 23 |
| Jiangsu Keling Medical Appliances Co., Ltd. | Yangzhou | Jiangsu | Contract manufacturer | 23 |
| Hebei Jiede Medical Equipment Co., Ltd. | Hengshui | Hebei | Contract manufacturer | 20 |
| Suzhou Number WIN Medical Technology Co., Ltd. | Zhangjiagang | Jiangsu | Manufacturer | 16 |
| Shandong Deman Medical Equipment Group Co., Ltd. | Jining | Shandong | Manufacturer | 11 |
| Nanchang Micare Medical Equipment Co., Ltd. | Nanchang | Jiangxi | Manufacturer | 8 |
| Nanjing Mindray BIO-Medical Electronics Co., Ltd. | Nanjing | Jiangsu | Manufacturer | 2 |
Record
| Listed by | Skytron, LLC, United States |
|---|---|
| FDA product code | FQO |
| Device type | Table, Operating-Room, Ac-Powered |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4960 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2021-10-20 |
| Record revised | 2026-01-01 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Over the counter | Yes |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, manufacturing date, serial number |
| Storage | Storage environment temperature -25 to 70 °C; Storage environment humidity 5 to 95 % RH |
| Sizes | Length 18.25 to 44 in |
| Distribution end date | 2026-01-01 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 4A-ERCA-13 Freedom | In distribution | ||
| 4A-SDOB Freedom | In distribution | ||
| 4A-PUS-22 Freedom | In distribution | ||
| 4A-VESA-CAM Freedom | In distribution | ||
| GS70-1 | In distribution | ||
| 4A-PUS-17 Freedom | In distribution | ||
| 4A-BHUA Freedom | In distribution | ||
| 4A-FHA Freedom | In distribution | ||
| 4A-VESA Freedom | In distribution | ||
| 4A-ERSU Freedom | In distribution | ||
| F410 SERIES Freedom | In distribution | ||
| 5-010-27-B | In distribution | ||
| 4A-ERSH-17 Freedom | In distribution | ||
| 4A-ERCS-10 Freedom | In distribution | ||
| 4A-PF32 Freedom | In distribution | ||
| 5-010-31-B | In distribution | ||
| 4A-SHC-32 Freedom | In distribution | ||
| F110 SERIES Freedom | In distribution | ||
| 3-060-09-2 | Length 18.25 in | In distribution | |
| F130 SERIES Freedom | In distribution | ||
| 4VSTH-CP1 Freedom | In distribution | ||
| 4A-CS-61 Freedom | In distribution | ||
| 4A-CS-49 Freedom | In distribution | ||
| 4A-PUK-22 Freedom | In distribution | ||
| 4A-ERCS-30 Freedom | In distribution | ||
| 4A-SHT-17 Freedom | In distribution | ||
| Freedom | In distribution | ||
| 4-031-01-C | In distribution | ||
| 4A-EXF-12 Freedom | In distribution | ||
| 4A-PF60 Freedom | In distribution | ||
| 3-060-09-1 | Length 18.25 in | In distribution | |
| 4A-KCVB Freedom | In distribution | ||
| 4A-CS-37 Freedom | In distribution | ||
| 6-020-10-6 | In distribution | ||
| 4A-SKDI Freedom | In distribution | ||
| 4A-HAB Freedom | In distribution | ||
| 5-010-22-3B-C | In distribution | ||
| 4-031-03 | Length 40 in | In distribution | |
| 4A-PD-ELO Freedom | In distribution | ||
| 4A-BD-2-22-B Freedom | In distribution | ||
| 3-040-22-1 | In distribution | ||
| 4KC-49 Freedom | In distribution | ||
| 5-010-09-2BL | In distribution | ||
| 5-010-29-D | In distribution | ||
| 4A-SHB-17 Freedom | In distribution | ||
| 4A-ERSB-13 Freedom | In distribution | ||
| 4A-ERSH-32 Freedom | In distribution | ||
| GS50 | In distribution | ||
| 5-010-28-B | In distribution | ||
| F200 SERIES Freedom | In distribution | ||
| 4A-ERCS-20 Freedom | In distribution | ||
| 4A-KCUB Freedom | In distribution | ||
| 4A-ERW-C Freedom | In distribution | ||
| 4A-BRAD Freedom | In distribution | ||
| 4A-FXS-BC72 Freedom | In distribution | ||
| 4A-PD-22-32 Freedom | In distribution | ||
| 4A-FPH-17 Freedom | In distribution | ||
| 4A-SUH-17 Freedom | In distribution | ||
| 6-020-10-9 | In distribution | ||
| 4A-FPH-22 Freedom | In distribution | ||
| 4A-BCC-49 Freedom | In distribution | ||
| F350 SERIES Freedom | In distribution | ||
| 4A-PD-KEY-N-V Freedom | In distribution | ||
| 4A-EXB-12 Freedom | In distribution | ||
| 4A-BD-1-22-B Freedom | In distribution | ||
| 4A-SHC-22 Freedom | In distribution | ||
| F221 SERIES Freedom | In distribution | ||
| 4VSTH-CP2 Freedom | In distribution | ||
| 5-010-31-4B | In distribution | ||
| 5-010-23-1B | In distribution | ||
| 5-010-27-3B | In distribution | ||
| F222 SERIES Freedom | In distribution | ||
| 4A-PD-22-22 Freedom | In distribution | ||
| 4A-BD-1-22-C Freedom | In distribution | ||
| 5-010-26-B | In distribution | ||
| 4A-HAS Freedom | In distribution | ||
| 4A-SHC-17 Freedom | In distribution | ||
| 5-010-21-4B | In distribution | ||
| 5-010-16-B | In distribution | ||
| 4A-CB-32 Freedom | In distribution | ||
| 3-060-09-6 | Length 22.8 in | In distribution | |
| 5-010-30-D | In distribution | ||
| 4A-BUD Freedom | In distribution | ||
| GS70H | In distribution | ||
| GS70-2 | In distribution | ||
| 4A-PD-CRD Freedom | In distribution | ||
| 4-031-02 | Length 23 in | In distribution | |
| 4A-BCC-37 Freedom | In distribution | ||
| 4A-BD-2-22-C Freedom | In distribution | ||
| 5-010-21-1B | In distribution | ||
| 4A-ERCS-15 Freedom | In distribution | ||
| 4A-PD-22-EX Freedom | In distribution | ||
| 5-010-22-3B-C1 | In distribution | ||
| F310 SERIES Freedom | In distribution | ||
| 4A-IVE-W Freedom | In distribution | ||
| 4A-PF37 Freedom | In distribution | ||
| 5-010-21-3B | In distribution | ||
| 3-060-09-4 | Length 24.8 in | In distribution | |
| 3-060-09-3 | Length 24.8 in | In distribution | |
| 4A-SHB-22 Freedom | In distribution | ||
| 4A-PF72 Freedom | In distribution | ||
| 5-010-21-2B | In distribution | ||
| 5-010-21-3NCB | In distribution | ||
| 4A-ERW-W Freedom | In distribution | ||
| 4A-EXU-12 Freedom | In distribution | ||
| F212 SERIES Freedom | In distribution | ||
| 4A-EXF-24 Freedom | In distribution | ||
| 5-010-22-3B | In distribution | ||
| 4A EXB-24 Freedom | In distribution | ||
| 5-010-23-B | In distribution | ||
| F440 SERIES Freedom | In distribution | ||
| 5-010-19-B | In distribution | ||
| 4A-LC-HM Freedom | In distribution | ||
| 3-060-09-5 | Length 22.8 in | In distribution | |
| 4A-FXS-BC60 Freedom | In distribution | ||
| 4A-PF66 Freedom | In distribution | ||
| 5-010-23-4B | In distribution | ||
| 4A-CA-SH Freedom | In distribution | ||
| F320 SERIES Freedom | In distribution | ||
| 4A-PD-17-17 Freedom | In distribution | ||
| F340 SERIES Freedom | In distribution | ||
| 4-041-01 | Length 19 in | In distribution | |
| 4A-CB-17 Freedom | In distribution | ||
| 5-010-22-B | In distribution | ||
| 4A-CB-22 Freedom | In distribution | ||
| 4A-ERSH-22 Freedom | In distribution | ||
| 4A-IVE-C Freedom | In distribution | ||
| 4A-VESA-PMO Freedom | In distribution | ||
| 5-010-16 | In distribution | ||
| GS70 | In distribution | ||
| 5-010-27-4B | In distribution | ||
| 4-030-42-9 | In distribution | ||
| 4-030-10-B | In distribution | ||
| 4A-SHF-48 Freedom | In distribution | ||
| 18-443-72 | In distribution | ||
| 4A-HSKV-17 Freedom | In distribution | ||
| 4A-ERCA-9 Freedom | In distribution | ||
| 4A-EXU-24 Freedom | In distribution | ||
| 4-031-01 | Length 44 in | In distribution | |
| 4A-PD-17-EX Freedom | In distribution | ||
| F20H SERIES Freedom | In distribution | ||
| 4A-HAC Freedom | In distribution | ||
| 4A-FXS-BC66 Freedom | In distribution | ||
| 4-030-13 | In distribution | ||
| 4A-ERBA Freedom | In distribution | ||
| F330 SERIES Freedom | In distribution | ||
| 5-010-16-3B | In distribution | ||
| F120 SERIES Freedom | In distribution | ||
| 4A-SUH-22 Freedom | In distribution | ||
| 4A-BHCO Freedom | In distribution | ||
| 5-010-27-2B | In distribution | ||
| F420 SERIES Freedom | In distribution | ||
| 4A-CA-UB Freedom | In distribution | ||
| 5-010-21-B | In distribution | ||
| 5-010-06-3B | Withdrawn | ||
| 5-010-10-3 | Withdrawn | ||
| 5-010-14-1B | Withdrawn | ||
| 4-031-04 | Withdrawn | ||
| 5-010-02-B | Withdrawn | ||
| 5-010-09-2B | Withdrawn | ||
| 5-010-02-2B | Withdrawn | ||
| 5-010-02-4B | Withdrawn | ||
| 3-040-22 | 12 | Withdrawn | |
| 5-010-19-2B | Withdrawn | ||
| 5-010-14-4 | Withdrawn | ||
| 5-010-02-3B | Withdrawn | ||
| 5-010-18-4B | Withdrawn | ||
| 4-090-17 | Withdrawn | ||
| 5-010-19-4B | Withdrawn | ||
| 5-010-21-BC | Withdrawn | ||
| 5-010-10-4B | Withdrawn | ||
| 5-010-22-3B C3 | Withdrawn | ||
| 5-010-02-1B | Withdrawn | ||
| 5-010-17-B | Withdrawn | ||
| 5-010-18-B | Withdrawn | ||
| 5-010-14-3B | Withdrawn | ||
| 5-010-10-3B | Withdrawn | ||
| 5-010-14-2B | Withdrawn | ||
| 5-010-09-4B | Withdrawn | ||
| 5-010-05-3B | Withdrawn | ||
| 4-090-17-2 | Withdrawn | ||
| 5-010-06-B | Withdrawn | ||
| 3-041-01 | Withdrawn | ||
| 5-010-09-3B | Withdrawn | ||
| 5-010-15-B | Withdrawn | ||
| 5-010-15-3B | Withdrawn | ||
| 5-010-09-2BC | Withdrawn | ||
| 5-010-05-B | Withdrawn | ||
| 5-010-19-1 | Withdrawn | ||
| 4-090-17-3 | Withdrawn | ||
| 5-010-09-B | Withdrawn | ||
| 5-010-10-2B | Withdrawn | ||
| 5-010-14-4B | Withdrawn | ||
| 5-010-10-B | Withdrawn | ||
| 4-090-17-1 | Withdrawn | ||
| 4-090-16 | Withdrawn | ||
| 3-040-33-1 | 12 | Withdrawn | |
| 5-010-19-3B | Withdrawn | ||
| 5-010-14-B | Withdrawn | ||
| 3-041-03 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| HarmonyAIR | Steris Corporation | 452 |
| Table, Operating-Room, Ac-Powered | Steris Corporation | 165 |
| iCE boom and Pendant | Amico Clinical Solutions | 102 |
| Mindray | Nanjing Mindray BIO-Medical Electronics Co., Ltd. | 95 |
| Amtai | Amtai Medical Equipment, Inc. | 95 |
| Steris | Steris Corporation | 72 |
| Alyon | Steris Corporation | 41 |
| Foot switch | Maquet Gmbh | 23 |
| Amsco | Steris Corporation | 14 |
| Atec A.R.M. | Alphatec Spine, Inc. | 13 |
| Universal table top | Maquet Gmbh | 13 |
| Magnus operating table system | Maquet Gmbh | 8 |
Showing 12 of 442. All products under Table, Operating-Room, Ac-Powered
Recalls Naming This Product
2 recalls name this product by its own identifiers, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| IHB Operations | UDI-DI | 2025-03-27 | Class II | Process change control | The mounting hardware that is supplied with the 4FXS-60 monitor bracket does not provide adequate thread engagement to support the weight of the frame and monitor. This could lead to a failure of the mounting hardware and subsequent separat | 112 units |
| IHB Operations | UDI-DI | 2023-07-19 | Class II | Device Design | Weakened connection point on the adjustable suspension arm, potentially causing damage or a break. | 1,497 |
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 |
|---|---|---|---|---|---|
| 2022-06-02 | Class II | Component design/selection | Under certain circumstances, the mounting screws may loosen or pull out from the attachment point on the Ergon 3 boom when the GCX Channel Mounting Accessory was used with the VST clamp as a monitor mount on the boom. | 731 | |
| 2021-05-11 | Class II | Device Design | Failure of the FS32 Monitor Brackets from the mounting block could potentially loosen over time and eventually detach from the baseplate, result in the display interface dismounting from its attachment point, causing injury to patients or s | 278 units US; 7 units OUS | |
| 2020-03-05 | Class II | Device Design | Potential for the weld to fail at the pivot point of the monitor bracket. This weld failure could cause the display interface and bracket to fall from its mounted location, resulting in injury. | 43 units | |
| 2016-03-28 | Class II | Process design | Potential for the weld to fail at the pivot point of the monitor bracket. This weld failure could cause the display interface and bracket to fall from its mounted location, resulting in injury. | 24 | 2017-07-25 |
| 2015-12-02 | Class II | Device Design | The hardware that holds the VESA plate and the display interface / monitor to the bracket may fail causing the display interface to fall from the bracket. Over time and with use the threaded rod hardware material can weaken and detach from | 286 | 2016-07-19 |
| 2005-08-04 | Not classified | Other | The release levers can inadvertently release under load while the leg section is positioned at a ninety degree angle causing the leg section to drop. | 160 total | 2008-05-01 |
| 2005-08-04 | Not classified | Other | The release levers can inadvertently release under load while the leg section is positioned at a ninety degree angle causing the leg section to drop. | 160 total | 2008-05-01 |
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.