Product Classification

• Device: therapeutic vibrational mattress pad, adjunct use in neonatal abstinence syndrome or neonatal opioid withdrawal syndrome
• Definition: Reusable hospital mattress pad with integrated mechanical vibrations to be used as adjunctive therapy for neonates and infants with neonatal abstinence syndrome (NAS) or neonatal opioid withdrawal syndrome (NOWS).
• Physical State: Hospital bassinet/bed mattress and mechanical vibration producing system
• Technical Method: Infant bassinet pad which provides stochastic vibrotactile stimulation
• Target Area: Full Body
• Regulation Medical Specialty: General Hospital
• Review Panel: General Hospital
• Product Code: QVY
• Premarket Review: Drug Delivery and General Hospital Devices, and Human Factors (DHT3C); Drug Delivery and General Hospital Devices, and Human Factors (DHT3C)
• Submission Type: 510(k)
• Regulation Number: 880.5151
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No
• Summary Malfunction Reporting: Ineligible
• Implanted Device?: No
• Life-Sustain/Support Device?: No

Third Party Review

Not Third Party Eligible