DeviceClearance

Product code QYN— Physical Medicine

Sana Device

Classification name
Prescription Audiovisual Stimulator (Avs) For Temporary Pain Relief (Adjunctive Use)
Device class
Class 1
Regulation
21 CFR 890.5775
Advisory panel
Physical Medicine
Total cleared
1
First cleared
Most recent

FDA classification definition

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

— U.S. Food and Drug Administration, device classification record for product code QYN under 21 CFR 890.5775, via openFDA

Market context for product code QYN

FDA has cleared 1 device under product code QYN, all in 2026, filed by 1 applicant company. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

Top applicants under product code QYN

Recent clearances under product code QYN

Data sourced from openFDA. This site is unofficial and independent of the FDA.