Identity
- Trade Name
- NEUROINFINITI 2 FDA UDI
- Generic Name
- Psychophysiological biofeedback system FDA UDI
- Model / Reference
- SA7904 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07540191000562 FDA UDI
- 510(k) Number
- K972723 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
Single Use
No
Implantable
No
Contains Latex
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
Yes
Category: Psychophysiological biofeedback system
The Neuroinfinite 2 is a comprehensive neurophysiological biofeedback system designed to assist patients in developing conscious control over involuntary functions. This device features multiple patient monitoring hardware, computer interface devices, and dedicated software, making it ideal for relaxation training and muscle re-education.
Similar devices
Also classified as Psychophysiological biofeedback system.
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- 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
K972723 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Thought Technology Ltd.
Sources (1)
- FDA UDI fc3627fc-4351-4bda-9bee-99cfc364d4cb 33 fields · synced Jul 24, 2026