Atlas FDA

QYN

1 FDA 510(k) clearances · Product code

FDA profile

Official device name
Prescription Audiovisual Stimulator (Avs) For Temporary Pain Relief (Adjunctive Use)
Device class
Class I (low risk)
Regulation
21 CFR 890.5775
Medical specialty
Physical Medicine
FDA definition
An AVS is a prescription use device intended for temporary pain relief and is used adjunctively with other pain therapies
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RecordFirmDate
Sana Device (DEN250005)Sana Health2026-01-16

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