A computerized device assembly designed for analysis and real-time feedback (biofeedback) of a variety of physiological parameters [e.g., heart rate, respiration, skin conductance, skin temperature, range of motion, force output, electroencephalography (EEG),
| Company | Devices | Share |
|---|---|---|
| Deymed Diagnostic S.R.O. | 67 | 34% |
| Thought Technology Ltd. | 53 | 27% |
| Myomo, Inc. | 22 | 11% |
| Delsys, Inc. | 18 | 9% |
| Prometheus Group Of New Hampshire Limited, The | 9 | 5% |
| Dorsavi Ltd | 8 | 4% |
| Cardinal Health 200, Llc | 5 | 3% |
| Intelligent System Co.,Ltd. | 4 | 2% |
| Exsurgo Limited | 3 | 2% |
| Amaze Neuro, Inc. | 2 | 1% |
| Jogohealth, Inc. | 2 | 1% |
| Freespira, Inc. | 2 | 1% |
Company = labeler of record on GUDID. 15 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 | 202 |
| IQI | Orthosis, Limb Brace | 22 |
| IRE | Joint, Elbow, External Limb Component, Powered | 22 |
| IQZ | Hand, External Limb Component, Powered | 22 |
| KPI | Stimulator, Electrical, Non-Implantable, For Incontinence | 5 |
| HCC | Device, biofeedback | 5 |
Use these as the dimensions to specify in a tender line.
198 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Psychophysiological biofeedback system", from 15 companies. The largest labeler is Deymed Diagnostic S.R.O. with 34% of records.
HCC (Device, Biofeedback), IQI (Orthosis, Limb Brace), IRE (Joint, Elbow, External Limb Component, Powered), IQZ (Hand, External Limb Component, Powered)
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.