An assembly of devices intended to provide visual and/or auditory signals corresponding to the status of one or more of a patient's physiological functions, e.g., brain wave activity, muscle activity, blood pressure, skin temperature, balance, so that the pati
| Company | Devices | Share |
|---|---|---|
| Delsys, Inc. | 22 | 43% |
| Ondamed Inc. | 16 | 31% |
| Corscience Gmbh & Co. Kg | 3 | 6% |
| 2Breathe Technologies Ltd | 2 | 4% |
| Nfant Labs Llc | 2 | 4% |
| Prometheus Group Of New Hampshire Limited, The | 2 | 4% |
| Motion Control, Inc | 1 | 2% |
| Control Bionics Incorporated | 1 | 2% |
| Intelligent Hearing Systems Corp. | 1 | 2% |
| Laborie Medical Technologies Canada Ulc | 1 | 2% |
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 |
|---|---|---|
| HCC | Device, Biofeedback | 49 |
| GWJ | Stimulator, Auditory, Evoked Response | 1 |
| HIR | PERINEOMETER | 1 |
| KPI | STIMULATOR, ELECTRICAL, NON-IMPLANTABLE, FOR INCONTINENCE | 1 |
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51 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Biofeedback system", from 10 companies. The largest labeler is Delsys, Inc. with 43% of records.
HCC (Device, Biofeedback), GWJ (Stimulator, Auditory, Evoked Response), HIR (PERINEOMETER), KPI (STIMULATOR, ELECTRICAL, NON-IMPLANTABLE, FOR INCONTINENCE)
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.