Keypoint
Natus Pattern Stimulator 22' TFT Display with Connection Kit
3manufacturers in China registered for this device type
44catalogue numbers in this listing
Who Else Makes It
Concentrated in Shandong (1), Shaanxi (1), Guangdong (1). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| Xian Friendship Medical Electronics Co., Ltd. | Xi’An | Shaanxi | Contract manufacturer | 10 |
| Shenzhen Launch Electrical Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 8 |
Record
| Listed by | Natus Manufacturing Limited, Ireland |
|---|---|
| FDA product code | GWF |
| Device type | Stimulator, Electrical, Evoked Response |
| Device class | Class 2 |
| Regulation | 21 CFR 882.1870 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K944547 |
| Record published | 2019-03-26 |
| Record revised | 2026-04-21 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | expiry date, manufacturing date, serial number |
| Distribution end date | 2026-04-21 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 9033S0611 | In distribution | |
| 9033S0731 | In distribution | |
| 9033S0721 | In distribution | |
| 9033S0551 | In distribution | |
| 9031E0155 | In distribution | |
| 9031E0712 | In distribution | |
| 9033S0656 | In distribution | |
| 9033S0691 | In distribution | |
| 9033S0541 | In distribution | |
| 9031C0732 | In distribution | |
| 9031E0277 | In distribution | |
| 9033G0704 | In distribution | |
| 9031E0223 | In distribution | |
| 9031B0521 | In distribution | |
| 9033C0731 | In distribution | |
| 9031E0172 | In distribution | |
| 9033S0531 | In distribution | |
| 9033S0571 | In distribution | |
| 9033A0721 | In distribution | |
| 9033A0711 | In distribution | |
| 9033A0701 | In distribution | |
| 9031C0771 | In distribution | |
| 9031F1124 | In distribution | |
| 9031D0411 | In distribution | |
| 9031D0401 | In distribution | |
| 9031C0762 | In distribution | |
| 9033S0711 | In distribution | |
| 9033S0628 | In distribution | |
| 9033S0031 | In distribution | |
| 9033S0511 | In distribution | |
| 9033S0591 | In distribution | |
| 9031A0701 | In distribution | |
| 9031C0742 | In distribution | |
| 9033S0601 | In distribution | |
| 9031E0402 | In distribution | |
| 9031E0722 | In distribution | |
| 9033S0131 | In distribution | |
| 9031S2308 | In distribution | |
| 9031C0782 | In distribution | |
| 9033S0581 | In distribution | |
| 9031G0186 | In distribution | |
| 9031E0258 | In distribution | |
| 9033S0521 | In distribution | |
| 9013L0241 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Stimulator, Electrical, Evoked Response | Inomed Medizintechnik Gmbh | 170 |
| Alpine BioMed | Alpine Biomed Aps | 132 |
| Natus | Natus Neurology Incorporated | 98 |
| Stimulator, Electrical, Evoked Response | Nihon Kohden America, Inc. | 41 |
| Stimulator, Electrical, Evoked Response | Nihon Kohden Corp. | 38 |
| Powerease™ Instruments | Medtronic Sofamor Danek, Inc. | 36 |
| Stimulator, Electrical, Evoked Response | Stryker Leibinger Gmbh & Co. KG | 29 |
| Natus | Xltek | 27 |
| Isis | Inomed Medizintechnik Gmbh | 26 |
| Xltek | Xltek | 24 |
| Natus Neurology | Natus Neurology Incorporated | 20 |
| Pulse | Nuvasive, Inc. | 16 |
Showing 12 of 121. All products under Stimulator, Electrical, Evoked Response
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Alpine Biomed Aps | 510(k) number | 2013-04-09 | Class II | Software design | Alpine Biomed ApS is recalling Natus neurology Dantec KEYPOINT.NET ver. 2.20 Software due to the presence of a software bug. | 871 licenses installed | 2014-01-06 |
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.