← FDA Medical Device Classifications
Sound Amplification Product
RHO · Not classified · Unknown
Classification
- FDA Product Code
RHO- Device class
- Not classified
- Regulation
- —
- Review panel
- —
- Medical specialty
- Unknown
- Submission type
- —
- GMP exempt
- Y
- Life sustaining
- —
- Implant
- —
- Third-party review
- —
Definition
Intended to amplify environmental sound for non-hearing impaired consumers
Market data
- Cleared 510(k) submissions
- 0
- Registered establishments
- 0
Source
- Authoritative
- FDA Device Classification database
- Machine
- JSON-LD · Markdown