QYN · Class I · 21 CFR 890.5775

FDA Product Code QYN: Prescription Audiovisual Stimulator (avs) For Temporary Pain Relief (adjunctive Use)

An Avs Is A Prescription Use Device Intended For Temporary Pain Relief And Is Used Adjunctively With Other Pain Therapies

Leading manufacturers include Sana Health.

1
Total
0
Cleared
319d
Avg days
2026
Since
Growing category - 1 submissions in the last 2 years vs 0 in the prior period

FDA 510(k) Cleared Prescription Audiovisual Stimulator (avs) For Temporary Pain Relief (adjunctive Use) Devices (Product Code QYN)

1 devices
1–1 of 1

About Product Code QYN - Regulatory Context

510(k) Submission Activity

1 total 510(k) submissions under product code QYN since 2026, with 0 receiving FDA clearance (average review time: 319 days).

Submission volume has increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.

QYN devices are reviewed by the Neurology panel. Browse all Neurology devices →