510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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QYNClass I

Prescription Audiovisual Stimulator (Avs) For Temporary Pain Relief (Adjunctive Use)

21 CFR 890.5775 / Physical Medicine
FDA source (opens on fda.gov)

QYN is the FDA product code for Prescription Audiovisual Stimulator (Avs) For Temporary Pain Relief (Adjunctive Use), a class I device type, regulated under 21 CFR 890.5775. FDA's definition for this code reads: "An AVS is a prescription use device intended for temporary pain relief and is used adjunctively with other pain therapies". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
QYN
Device name
Prescription Audiovisual Stimulator (Avs) For Temporary Pain Relief (Adjunctive Use)
FDA definition
An AVS is a prescription use device intended for temporary pain relief and is used adjunctively with other pain therapies
Regulation
21 CFR 890.5775
Device class
Class I
Review panel
Physical Medicine
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
1
Ingested recalls
0

Clearances, product code QYN

By decision year
1 clearance under product code QYN with a decision year between 2026 and 2026, 2026 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code QYN by decision year
YearClearances
20261

Applicants with the most clearances

Product code QYN
Applicants holding the most 510(k) clearances under product code QYN
ApplicantClearances
Sana Health, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code