Product Classification

• Device: computerized cognitive assessment aid for concussion
• Regulation Description: Computerized cognitive assessment aid for concussion.
• Definition: For use as an assessment aid in the management of concussion.
• Physical State: The device consists of a software program that administers a neurocognitive test battery to a subject in order to assess their cognitive status. The device may use off-the-shelf computers or a novel device.
• Technical Method: Uses a software-based cognitive test battery as an assessment aid in the management of concussion.
• Target Area: Brain
• Regulation Medical Specialty: Neurology
• Review Panel: Neurology
• Product Code: POM
• Premarket Review: Neurosurgical, Neurointerventional and Neurodiagnostic Devices (DHT5A); Neurosurgical, Neurointerventional and Neurodiagnostic Devices (DHT5A)
• Submission Type: 510(k)
• Regulation Number: 882.1471
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No
• Summary Malfunction Reporting: Eligible
• Implanted Device?: No
• Life-Sustain/Support Device?: No

Third Party Review

Not Third Party Eligible