QYN · Prescription Audiovisual Stimulator (Avs) For Temporary Pain Relief (Adjunctive Use)
Physical Medicine · 21 CFR 890.5775 · Class 1
Overview
| Product Code | QYN |
|---|---|
| Device Name | Prescription Audiovisual Stimulator (Avs) For Temporary Pain Relief (Adjunctive Use) |
| Regulation | 21 CFR 890.5775 |
| Device Class | Class 1 |
| Review Panel | Physical Medicine |
Identification
An audio-visual stimulator for pain relief is a device intended to deliver light stimuli to the eyes and sound stimuli to the ears to provide pain relief. This device is intended to be used adjunctively to other modes of therapy to relieve pain. The Sana Device is indicated for patients aged 18 and older as an adjunct to other modes of therapy for temporary relief of neuropathic pain for use at home or in the clinic.
Classification Rationale
FDA concludes that this device should be classified into Class I. FDA believes that class I (general) controls provide reasonable assurance of the safety and effectiveness of the device type.
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| DEN250005 | Sana Device | Sana Health | Jan 16, 2026 | DENG |
Top Applicants
- Sana Health — 1 clearance
