← FDA Medical Device Classifications
Prescription Audiovisual Stimulator (Avs) For Temporary Pain Relief (Adjunctive Use)
QYN · Class I — Low Risk (general controls) · Physical Medicine · 21 CFR 890.5775
Classification
- FDA Product Code
QYN- Device class
- Class I — Low Risk (general controls)
- Regulation
- 21 CFR 890.5775
- Review panel
- NE
- Medical specialty
- Physical Medicine
- Submission type
- 4
- GMP exempt
- N
- Life sustaining
- N
- Implant
- N
- Third-party review
- N
Definition
An AVS is a prescription use device intended for temporary pain relief and is used adjunctively with other pain therapies
Market data
- Cleared 510(k) submissions
- 1
- Registered establishments
- 0
Source
- Authoritative
- FDA Device Classification database
- Machine
- JSON-LD · Markdown