Natus
Natus Elite v2 Software Upgrade with New System Order
3manufacturers in China registered for this device type
98catalogue numbers in this listing
3510(k) clearances naming this product code
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 Neurology Incorporated, United States |
|---|---|
| FDA product code | GWF |
| Device type | Stimulator, Electrical, Evoked Response |
| Device class | Class 2 |
| Regulation | 21 CFR 882.1870 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K093304 |
| Record published | 2023-10-27 |
| Record revised | 2023-10-09 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 828-080000 | In distribution | |
| 002506 | In distribution | |
| 048778 | In distribution | |
| 040K010 | In distribution | |
| 040K152 | In distribution | |
| 482-652000U | In distribution | |
| 071-423800 | In distribution | |
| 043312 | In distribution | |
| 688-628600 | In distribution | |
| 842-202300 | In distribution | |
| 043311 | In distribution | |
| 031D068 | In distribution | |
| 017609 | In distribution | |
| 085-477100 | In distribution | |
| 842-692100 | In distribution | |
| 040C001 | In distribution | |
| 017608 | In distribution | |
| 040K039 | In distribution | |
| 040K010 | In distribution | |
| 040K011 | In distribution | |
| 828-069700 | In distribution | |
| 071-422900 | In distribution | |
| 828-080300 | In distribution | |
| 036C001 | In distribution | |
| 040K031 | In distribution | |
| 045108 | In distribution | |
| 688-630100 | In distribution | |
| 033418 | In distribution | |
| 031K074 | In distribution | |
| 515-016600 | In distribution | |
| 040C010 | In distribution | |
| 688-630000 | In distribution | |
| 842-691900 | In distribution | |
| 033100 | In distribution | |
| 071-423600 | In distribution | |
| 982A0597 | In distribution | |
| 033417 | In distribution | |
| 842-648300 | In distribution | |
| 482-651200 | In distribution | |
| 482-645900 | In distribution | |
| 828-080100 | In distribution | |
| 515-013300 | In distribution | |
| 040K022 | In distribution | |
| 071-423700 | In distribution | |
| 085-478900 | In distribution | |
| 688-630400 | In distribution | |
| 017606 | In distribution | |
| 033415 | In distribution | |
| 040K012 | In distribution | |
| 035344 | In distribution | |
| 842-692200 | In distribution | |
| 515-016300 | In distribution | |
| 085-458000 | In distribution | |
| 842-690100 | In distribution | |
| 085-456700 | In distribution | |
| 842-647900 | In distribution | |
| 842-692000 | In distribution | |
| Elite-VS-V2 | In distribution | |
| 515-013400 | In distribution | |
| 043281 | In distribution | |
| 842-691800 | In distribution | |
| 515-013100 | In distribution | |
| 022332 | In distribution | |
| 982A0569 | In distribution | |
| 515-013200 | In distribution | |
| 982A0594 | In distribution | |
| 828-069300 | In distribution | |
| 031D041 | In distribution | |
| 071-500600 | In distribution | |
| 046958 | In distribution | |
| 031D042 | In distribution | |
| 828-069400 | In distribution | |
| 022330 | In distribution | |
| 033416 | In distribution | |
| 688-630300 | In distribution | |
| 698-633700 | In distribution | |
| 688-630200 | In distribution | |
| 071-423500 | In distribution | |
| 040C002 | In distribution | |
| 828-080200 | In distribution | |
| 031D035 | In distribution | |
| 828-069500 | In distribution | |
| 031K025 | In distribution | |
| 515-018800 | In distribution | |
| 031K040 | In distribution | |
| 031D067 | In distribution | |
| 031D043 | In distribution | |
| 515-016500 | In distribution | |
| 017806 | In distribution | |
| 085-746400 | In distribution | |
| 842-202700 | In distribution | |
| 482-649300 | In distribution | |
| 482-647500 | In distribution | |
| 017112 | In distribution | |
| 482-645500 | In distribution | |
| 040C009 | In distribution | |
| 688-628500 | In distribution | |
| 044886 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Stimulator, Electrical, Evoked Response | Inomed Medizintechnik Gmbh | 170 |
| Alpine BioMed | Alpine Biomed Aps | 132 |
| 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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K243982 | 2025-01-22 |
| K243495 | 2024-12-12 |
| K130346 | 2013-05-02 |
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.