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QYN — Prescription Audiovisual Stimulator (Avs) For Temporary Pain Relief (Adjunctive Use) Class I

FDA Device Classification

Classification Details

Product Code: QYN
Device Class: Class I
Regulation Number: 890.5775
Submission Type
Review Panel: NE
Medical Specialty: Physical Medicine
Implant: No

Definition

An AVS is a prescription use device intended for temporary pain relief and is used adjunctively with other pain therapies

Recent 510(k) Clearances

K-Number	Applicant	Device Name	Date
DEN250005	sana health	Sana Device	January 16, 2026