Last synced on 16 May 2025 at 11:05 pm

Sound Amplification Product

Page Type
Product Code
Definition
Intended to amplify environmental sound for non-hearing impaired consumers
Device Classification
N
GMP Exempt?
Yes
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

No Linked CFR Text

As product code RHO is assigned to devices that are "not-classified", it is not linked to any specific regulation and CFR section.

Sound Amplification Product

Page Type
Product Code
Definition
Intended to amplify environmental sound for non-hearing impaired consumers
Device Classification
N
GMP Exempt?
Yes
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

No Linked CFR Text

As product code RHO is assigned to devices that are "not-classified", it is not linked to any specific regulation and CFR section.