Product code QYN

Device name
Prescription Audiovisual Stimulator (Avs) For Temporary Pain Relief (Adjunctive Use)
Medical specialty
Physical Medicine
Device class
1
Regulation number
890.5775
Review panel
NE
Implant
N
Life sustaining/supporting
N
GMP exempt
N
Third party review
N
Summary malfunction reporting
Ineligible
Definition
An AVS is a prescription use device intended for temporary pain relief and is used adjunctively with other pain therapies
Source
FDA openFDA device classification dataset

Related 510(k) Records

510(k)DeviceApplicantDecision date
DEN250005Sana DeviceSana Health2026-01-16