Identity
- Trade Name
- EEG-Z3 FDA UDI
- Generic Name
- Psychophysiological biofeedback system FDA UDI
- Model / Reference
- SA7680Z FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07540191000128 FDA UDI
- 510(k) Number
- K903497 FDA UDI
- FDA Product Code
- HCC FDA UDI
- GMDN Term
- Psychophysiological biofeedback system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.5050 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Psychophysiological biofeedback system
Eeg-Z3 by Thought Technology Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Psychophysiological biofeedback system.
- Axon — EXSURGO LIMITED · Class II
- dorsaVi — DORSAVI LTD · Class II
- Trigno Avanti Mini Sensor — DELSYS, INC. · Class II
- Pathway — PROMETHEUS GROUP OF NEW HAMPSHIRE LIMITED, THE · Class II
- FlexiCAP — DEYMED Diagnostic s.r.o. · Class II
- MyoPro — Myomo, Inc. · Class II
- Axon 2 — EXSURGO LIMITED · Class II
- Pathway — PROMETHEUS GROUP OF NEW HAMPSHIRE LIMITED, THE · Class II
Cleared under the same submission
K903497 also covers:
- 100 Triodes Self Adhesive — Thought Technology Ltd.
- Bend Sensor Assembly — Thought Technology Ltd.
- DC-EEG 3 DISC ELECTRODE KIT — Thought Technology Ltd.
- DC-EEG LINKED EAR ATTACHMENT KIT — Thought Technology Ltd.
- DC-EEG MONO/BIPOLAR ELECTRODE KIT — Thought Technology Ltd.
- DC-EEG TWO CHANNEL CONNECTIVIT KIT — Thought Technology Ltd.
- EKG Receiver for Polar — Thought Technology Ltd.
- Electrodes 100 Unigel Single — Thought Technology Ltd.
- Flexcomp Infiniti Encoder — Thought Technology Ltd.
- Forcetrac — Thought Technology Ltd.
- Inclinotrac Sensor — Thought Technology Ltd.
- Procomp 2 Encoder Device — Thought Technology Ltd.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Thought Technology Ltd.
Sources (1)
- FDA UDI d2721715-3a44-4c12-b926-f35c72116a7f 33 fields · synced May 31, 2026