An assembly of devices designed for recording a localized electrical potential from the brain or spinal cord in response to stimulation (i.e., visual, auditory, and/or somatosensory) of the sensory organs, or of some point along the ascending pathway from the
| Company | Devices | Share |
|---|---|---|
| Nihon Kohden Corporation | 38 | 30% |
| Nihon Kohden America, Inc. | 36 | 28% |
| Intelligent Hearing Systems Corp. | 18 | 14% |
| Innara Health, Inc. | 11 | 9% |
| Eb Neuro Spa | 11 | 9% |
| Headsafe Mfg Pty Ltd | 7 | 6% |
| Laborie Medical Technologies Canada Ulc | 3 | 2% |
| Quantalx Neuroscience Ltd | 1 | 1% |
| Fhc, Inc. | 1 | 1% |
| Frye Electronics, Inc. | 1 | 1% |
Company = labeler of record on GUDID. 10 companies in total; top 12 shown. Click headers to sort.
Sample of brand names as labelled; no endorsement. Ask us for the full list with company, model and UDI.
| Code | Name | Devices |
|---|---|---|
| GWF | STIMULATOR, ELECTRICAL, EVOKED RESPONSE | 43 |
| IKN | Electromyograph, diagnostic | 41 |
| GWF | Stimulator, Electrical, Evoked Response | 29 |
| GWJ | Stimulator, Auditory, Evoked Response | 29 |
| IKN | Electromyograph, Diagnostic | 23 |
| HCC | Device, biofeedback | 11 |
Use these as the dimensions to specify in a tender line.
127 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Evoked-potential graphic recording system", from 10 companies. The largest labeler is Nihon Kohden Corporation with 30% of records.
GWF (STIMULATOR, ELECTRICAL, EVOKED RESPONSE), IKN (Electromyograph, diagnostic), GWF (Stimulator, Electrical, Evoked Response), GWJ (Stimulator, Auditory, Evoked Response)
No. GUDID is the US register. For the UAE (MOHAP/DoH) and Saudi (SFDA/MDMA) a separate registration and a local authorised representative are required; Consulting Wallah can check the status and connect you with registered suppliers.
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Source: FDA AccessGUDID (AccessGUDID full release 2 Nov 2026); counts are device records in commercial distribution grouped by GMDN preferred term; companies are labelers of record. Information only — US listing is not a registration in the UAE or GCC; verify with the regulator. © Consulting Wallah — CC BY‑NC‑ND.