Natus Neurology
VIK EDX CONTROL PANEL-ENGLISH - Demo
2manufacturers in China registered for this device type
21catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Shandong (1), Shaanxi (1). 2 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 |
Record
| Listed by | Natus Neurology Incorporated, United States |
|---|---|
| FDA product code | IKN |
| Device type | Electromyograph, Diagnostic |
| Device class | Class 2 |
| Regulation | 21 CFR 890.1375 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K112052 |
| Record published | 2016-09-16 |
| Record revised | 2022-11-28 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 842-689400 | In distribution | |
| 515-020300 | In distribution | |
| 713-414000F | In distribution | |
| DM-982A0568 | In distribution | |
| 672-106100 | In distribution | |
| 842-115000 | In distribution | |
| 842-689700-DS | In distribution | |
| 842-689700 | In distribution | |
| DM-515-015300 | In distribution | |
| 842-106504 | In distribution | |
| 842-689900 | In distribution | |
| 842-116700 | In distribution | |
| 842-129800 | In distribution | |
| DM-842-689400 | In distribution | |
| 842-127500 | In distribution | |
| 713-413300F | In distribution | |
| 713-410701F | In distribution | |
| 842-129700 | In distribution | |
| 672-106200 | In distribution | |
| DM-982A0474 | In distribution | |
| 842-689900-DS | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Electromyograph, Diagnostic | Medtronic Xomed, Inc. | 36 |
| Natus | Natus Neurology Incorporated | 21 |
| NVM5 | Nuvasive, Inc. | 19 |
| Epad | Safeop Surgical, Inc. | 18 |
| Pulse | Nuvasive, Inc. | 16 |
| Electromyograph, Diagnostic | Nihon Kohden Corp. | 16 |
| Electromyograph, Diagnostic | Nihon Kohden America, Inc. | 15 |
| Natus | Xltek | 14 |
| Neuropack S3 | Nihon Kohden Corp. | 8 |
| Electromyograph, Diagnostic | Medtronic Sofamor Danek, Inc. | 7 |
| MyoVision Software | Precision Biometrics, Inc. | 5 |
| SafeOp | Alphatec Spine, Inc. | 4 |
Showing 12 of 49. All products under Electromyograph, Diagnostic
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K172743 | 2017-12-19 |
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.