K254004

VRNT is a digital therapeutic device — product code QRA covers FDA-cleared software-based treatment interventions, including virtual reality therapy applications. Cognifisense has focused on VR-delivered chronic pain management, placing VRNT in the growing neurological-digital-therapeutic segment.

Neurology panel, Special 510(k) — the Special pathway indicates this is a modification to a previously cleared device by the same applicant, which means the substantial equivalence argument is against Cognifisense's own prior clearance rather than an external predicate.

Cognifisense, Inc. files from Sunnyvale, CA. Four-month clock, typical for Special 510(k). QRA is a young product code — it expanded substantially after FDA's 2017 digital-therapeutic guidance reshaped how software-only behavioral interventions were classified.