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| Product | Model | Company | Device type |
|---|---|---|---|
| Canvas DxCognoa, Inc.Neurodevelopmental disorder interpretive software | 1.3.0 | Cognoa, Inc. | Neurodevelopmental disorder interpretive software |
| Cognition Snapshot+ 2.2.0Qr8 Health IncCognitive assessment software | SNP-COG-22 | Qr8 Health Inc | Cognitive assessment software |
| CT-132 (Selene)Click Therapeutics, Inc.Pain relief/management therapeutic software | v2.x.x | Click Therapeutics, Inc. | Pain relief/management therapeutic software |
| DANA™Anthrotronix, Inc.Cognitive assessment software | 1.0 | Anthrotronix, Inc. | Cognitive assessment software |
| EndeavorRx™Akili Interactive Labs, Inc.Mental health/function therapeutic software, screen-viewed | Treatment 1 | Akili Interactive Labs, Inc. | Mental health/function therapeutic software, screen-viewed |
| Happyneuron Cognitive TrainingHappyneuronMental health/function therapeutic software, screen-viewed | Version 1 | Happyneuron | Mental health/function therapeutic software, screen-viewed |
| ImPACT PediatricImpact Applications, Inc.Cause-and-effect assistive training device | ImPACT Pediatric | Impact Applications, Inc. | Cause-and-effect assistive training device |
| ImPACT Quick TestImpact Applications, Inc.Cognitive assessment software | 2 | Impact Applications, Inc. | Cognitive assessment software |
| K-D BalanceKing-Devick Test, Inc.Sports concussion screening software | 2.0 | King-Devick Test, Inc. | Sports concussion screening software |
| Mahana IBSMahana Therapeutics, Inc.Mental health/function therapeutic software, screen-viewed | 01-0003-001 | Mahana Therapeutics, Inc. | Mental health/function therapeutic software, screen-viewed |
| Parallel(TM)Mahana Therapeutics, Inc.Mindfulness/behavioural therapy software, non-clinician-consultative | 01-0001-001 | Mahana Therapeutics, Inc. | Mindfulness/behavioural therapy software, non-clinician-consultative |
| Proliv®Rx Mobile Application (iOS)Neurolief LtdCranial/cervical nerve transcutaneous electrical stimulation system software | SW-APP-1003 | Neurolief Ltd | Cranial/cervical nerve transcutaneous electrical stimulation system software |
| QbTestQbtech ABPsychological assessment software | QbTest | Qbtech AB | Psychological assessment software |
| RelieVRxAppliedvr, Inc.Pain relief virtual reality system | RVX-2001 | Appliedvr, Inc. | Pain relief virtual reality system |
| RelieVRxAppliedvr, Inc.Pain relief virtual reality system | RVX-2042 | Appliedvr, Inc. | Pain relief virtual reality system |
| RelieVRxAppliedvr, Inc.Pain relief virtual reality system | RVX-3012 | Appliedvr, Inc. | Pain relief virtual reality system |
| reSET-O® Demo Version (Mobile App, iOS)Pear Therapeutics, Inc.Mental health/function therapeutic software, screen-viewed | 1 | Pear Therapeutics, Inc. | Mental health/function therapeutic software, screen-viewed |
| reSET®Pear Therapeutics, Inc.Mental health/function therapeutic software, screen-viewed | 1 | Pear Therapeutics, Inc. | Mental health/function therapeutic software, screen-viewed |
| reSET® Demo Version (Mobile App, iOS)Pear Therapeutics, Inc.Mental health/function therapeutic software, screen-viewed | 1 | Pear Therapeutics, Inc. | Mental health/function therapeutic software, screen-viewed |
| SleepioRxBig Health Inc.Mental health/function therapeutic software, screen-viewed | v1 | Big Health Inc. | Mental health/function therapeutic software, screen-viewed |
| SMART TSFSmith & Nephew, Inc.Wireless patient monitor/sensor reporting software, layperson-use | 71075403 | Smith & Nephew, Inc. | Wireless patient monitor/sensor reporting software, layperson-use |
| StanzaXr Health Il LtdMental health/function therapeutic software, screen-viewed | REIN | Xr Health Il Ltd | Mental health/function therapeutic software, screen-viewed |
| T.O.V.A.Tova Company, theCognitive assessment software | Software | Tova Company, the | Cognitive assessment software |
| VRCogniXr Health Il LtdMental health/function therapeutic software, screen-viewed | CT-620 (Memorize) | Xr Health Il Ltd | Mental health/function therapeutic software, screen-viewed |