510(k) K242214
K242214 is an FDA 510(k) premarket notification submitted by Sound Health Systems, Inc. for the device "Sonu". The FDA issued a decision of Substantially Equivalent on April 24, 2025. The device falls under product code QZC (External Mechanical Stimulator For The Relief Of Congestion), a Class II device regulated under 21 CFR 874.6010. Sound Health Systems, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 24, 2025
- Date Received
- July 29, 2024
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- External Mechanical Stimulator For The Relief Of Congestion
- Device Class
- Class II
- Regulation Number
- 874.6010
- Review Panel
- EN
- Submission Type
The external mechanical stimulator for the relief of congestion delivers vibrations to the sinus and nasal areas to relieve congestion.