Natus
Auditory Stimulation Headphones FOR Xltek Neuromax
2manufacturers in China registered for this device type
14catalogue numbers in this listing
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 | Xltek, Canada |
|---|---|
| FDA product code | IKN |
| Device type | Electromyograph, Diagnostic |
| Device class | Class 2 |
| Regulation | 21 CFR 890.1375 |
| 510(k) | K941144 |
| Record published | 2016-09-13 |
| Record revised | 2026-05-13 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date, serial number |
| Distribution end date | 2023-07-03 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 101963XL | In distribution | |
| 10442 | In distribution | |
| 101487 | In distribution | |
| 102610 | In distribution | |
| 10058 | In distribution | |
| 10434 | In distribution | |
| 10435 | In distribution | |
| 001927 | In distribution | |
| 10438 | In distribution | |
| 104037 | Withdrawn | |
| 007878 | Withdrawn | |
| 10359 | Withdrawn | |
| 102762 | Withdrawn | |
| 10328 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Electromyograph, Diagnostic | Medtronic Xomed, Inc. | 36 |
| Natus | Natus Neurology Incorporated | 21 |
| Natus Neurology | 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 |
| 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
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.