Product code QYN
- Device name
- Prescription Audiovisual Stimulator (Avs) For Temporary Pain Relief (Adjunctive Use)
- Medical specialty
- Physical Medicine
- Device class
- 1
- Regulation number
- 890.5775
- Review panel
- NE
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- Definition
- An AVS is a prescription use device intended for temporary pain relief and is used adjunctively with other pain therapies
- Source
- FDA openFDA device classification dataset
Related 510(k) Records
| 510(k) | Device | Applicant | Decision date |
|---|
| DEN250005 | Sana Device | Sana Health | 2026-01-16 |