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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device virtual reality behavioral therapy device for pain relief
Regulation Description Virtual reality behavioral therapy device for pain relief.
Definition A virtual reality behavioral therapy device for pain relief is a device intended to provide behavioral therapy for patients with pain. Therapy is administered via a virtual reality display which utilizes a software program containing the behavioral therapy content.
Product CodeQRA
Regulation Number 890.5800
Device Class 2


Premarket Reviews
ManufacturerDecision
APPLIEDVR
  SUBSTANTIALLY EQUIVALENT 2
APPLIEDVR, INC.
  GRANTED 1
COGNIFISENSE, INC.
  SUBSTANTIALLY EQUIVALENT 2
SMILEYSCOPE HOLDING, INC.
  SUBSTANTIALLY EQUIVALENT 1

Recalls
Manufacturer Recall Class Date Posted
1 Appliedvr II Jun-30-2023
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