510(k) DEN210033
DEN210033 is an FDA 510(k) premarket notification submitted by Neuromod Devices Limited for the device "Lenire Tinnitus Treatment Device". The FDA issued a decision of De Novo Granted on March 6, 2023. The device falls under product code QVN (Combined Acoustic And Electrical External Stimulation Device For The Relief Of Tinnitus), a Class II device regulated under 21 CFR 874.3410.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- March 6, 2023
- Date Received
- August 18, 2021
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Combined Acoustic And Electrical External Stimulation Device For The Relief Of Tinnitus
- Device Class
- Class II
- Regulation Number
- 874.3410
- Review Panel
- EN
- Submission Type
A combined acoustic and electrical external stimulation device for the relief of tinnitus is a device that provides acoustic stimulation in the ear and external, electrical stimulation of sensory nerves to relieve tinnitus.