FDA product code RHO
Sound Amplification Product
UnknownClass N21 CFR
US regulatory classifications
- US Risk Class (FDA)
- Class N
- Medical specialty
- Unknown
Device characteristics
- GMP exempt
- Yes
- Implantable
- No
- Life-sustaining
- No
Definition
Intended to amplify environmental sound for non-hearing impaired consumers
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About this record
Sound Amplification Product is a medical device type in the Unknown specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.
View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.