Alpine BioMed
"Keypoint Focus Workstation, Intl. 115V (ENG) Including: - USFF PC with Keypoint software, 22” display - Keypoint Focus main unit with control panel, integrated speakers, EP stimulators -…
“Keypoint Focus Workstation, Intl. 115V (ENG) Including: – USFF PC with Keypoint software, 22” display – Keypoint Focus main unit with control panel, integrated speakers, EP stimulators – Cart with isolating power supply – System kit”
3manufacturers in China registered for this device type
132catalogue numbers in this listing
1recall
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 | Alpine Biomed Aps, Denmark |
|---|---|
| FDA product code | GWF |
| Device type | Stimulator, Electrical, Evoked Response |
| Device class | Class 2 |
| Regulation | 21 CFR 882.1870 |
| 510(k) | K944547 |
| Record published | 2016-08-25 |
| Record revised | 2022-11-28 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date, serial number |
| Distribution end date | 2020-04-28 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 9031D0401 | In distribution | |
| 9031A051303 | Withdrawn | |
| 9033A0721HA | Withdrawn | |
| 9031C0312 | Withdrawn | |
| 9033A0711BV | Withdrawn | |
| 9031C0311 | Withdrawn | |
| 9033A072104 | Withdrawn | |
| 9033A072102 | Withdrawn | |
| 9031A051406 | Withdrawn | |
| 9031A051402 | Withdrawn | |
| 9033A071143 | Withdrawn | |
| 9031G0186 | Withdrawn | |
| 9031C0522 | Withdrawn | |
| 9031C0511 | Withdrawn | |
| 9033A0711GN | Withdrawn | |
| 9031D0411 | Withdrawn | |
| 9031A006405 | Withdrawn | |
| 9031G0711 | Withdrawn | |
| 9033A071106 | Withdrawn | |
| 9031A0701AA | Withdrawn | |
| 9031A070106 | Withdrawn | |
| 9031A006505 | Withdrawn | |
| 9031E0402 | Withdrawn | |
| 9031E0277 | Withdrawn | |
| 9031E0258 | Withdrawn | |
| 9031C0553 | Withdrawn | |
| 9033A072143 | Withdrawn | |
| 9031A0514AA | Withdrawn | |
| 9033A072101 | Withdrawn | |
| 9031A0701 | Withdrawn | |
| 9033A1712 | Withdrawn | |
| 9031E0153 | Withdrawn | |
| 8031C0511 | Withdrawn | |
| 9031A006402 | Withdrawn | |
| 9031C0503 | Withdrawn | |
| 9033G0703 | Withdrawn | |
| 9033A071101 | Withdrawn | |
| 9031E0722 | Withdrawn | |
| 9031A0064AA | Withdrawn | |
| 9031E0154 | Withdrawn | |
| 9031E0721 | Withdrawn | |
| 9031E0268 | Withdrawn | |
| 9033A0711CN | Withdrawn | |
| 9033C0731 | Withdrawn | |
| 9031E0155 | Withdrawn | |
| 9031E0126 | Withdrawn | |
| 9033A072103 | Withdrawn | |
| 9031G0701 | Withdrawn | |
| 9031A006502 | Withdrawn | |
| 9033A071104 | Withdrawn | |
| 9031C0551 | Withdrawn | |
| 9031C0761 | Withdrawn | |
| 9031A006503 | Withdrawn | |
| 9031C0502 | Withdrawn | |
| 9031A006401 | Withdrawn | |
| 9031C0523 | Withdrawn | |
| 9031C0762 | Withdrawn | |
| 9031E0712 | Withdrawn | |
| 9031C0781 | Withdrawn | |
| 9031C0782 | Withdrawn | |
| 9031C0601 | Withdrawn | |
| 9031E0223 | Withdrawn | |
| 8031C0731 | Withdrawn | |
| 9033A0721BV | Withdrawn | |
| 9031A070102 | Withdrawn | |
| 9033A0701CN | Withdrawn | |
| 9031C0512 | Withdrawn | |
| 9031C0512 | Withdrawn | |
| 9031A0701BV | Withdrawn | |
| 9031A051305 | Withdrawn | |
| 9031A006406 | Withdrawn | |
| 9031A051301 | Withdrawn | |
| 9031A051302 | Withdrawn | |
| 8031C0781 | Withdrawn | |
| 9033A0701 | Withdrawn | |
| 9033A0721GN | Withdrawn | |
| 9031E0711 | Withdrawn | |
| 9033A1801 | Withdrawn | |
| 9031G0702 | Withdrawn | |
| 9031E0172 | Withdrawn | |
| 9033A071105 | Withdrawn | |
| 9031A0513AA | Withdrawn | |
| 9031A006404 | Withdrawn | |
| 9033A0711AA | Withdrawn | |
| 8031C0761 | Withdrawn | |
| 9031A0701HA | Withdrawn | |
| 9031C0731 | Withdrawn | |
| 9031C0501 | Withdrawn | |
| 9031A070101 | Withdrawn | |
| 9031E0134 | Withdrawn | |
| 9031E0116 | Withdrawn | |
| 8031C0551 | Withdrawn | |
| 9031C0552 | Withdrawn | |
| 9033A071102 | Withdrawn | |
| 9031A070103 | Withdrawn | |
| 9031A051304 | Withdrawn | |
| 9031E0171 | Withdrawn | |
| 9031A051306 | Withdrawn | |
| 9031C0771 | Withdrawn | |
| 9033A072106 | Withdrawn | |
| 9031G0703 | Withdrawn | |
| 9031D0303 | Withdrawn | |
| 9031A051403 | Withdrawn | |
| 9031A0065HA | Withdrawn | |
| 9031A070104 | Withdrawn | |
| 9033G0704 | Withdrawn | |
| 9031A006403 | Withdrawn | |
| 9031A006506 | Withdrawn | |
| 9031A0701GN | Withdrawn | |
| 9033A071103 | Withdrawn | |
| 9031A070105 | Withdrawn | |
| 8031C0521 | Withdrawn | |
| 9031C0732 | Withdrawn | |
| 9031A006504 | Withdrawn | |
| 9031C0302 | Withdrawn | |
| 9033A072105 | Withdrawn | |
| 8031C0501 | Withdrawn | |
| 9031C5623 | Withdrawn | |
| 9033A0721CN | Withdrawn | |
| 9031A0701CN | Withdrawn | |
| 9080D1094 | Withdrawn | |
| 9031A0065AA | Withdrawn | |
| 9031A051405 | Withdrawn | |
| 9031A051404 | Withdrawn | |
| 9031C0602 | Withdrawn | |
| 9031E0144 | Withdrawn | |
| 9031E0153 | Withdrawn | |
| 9031A051401 | Withdrawn | |
| 9033A0711HA | Withdrawn | |
| 9031C0521 | Withdrawn | |
| 9031A006501 | Withdrawn | |
| 9033A0721AA | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Stimulator, Electrical, Evoked Response | Inomed Medizintechnik Gmbh | 170 |
| Natus | Natus Neurology Incorporated | 98 |
| Keypoint | Natus Manufacturing Limited | 44 |
| 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.