510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
DEN230045Unknown

Sonu

Sound Health Systems, Inc., Los Altos CA / Direct, Unknown
FDA source (opens on fda.gov)

DEN230045 is the FDA 510(k) clearance record for Sonu, a class II device, cleared for Sound Health Systems, Inc. on under FDA product code QZC (External Mechanical Stimulator For The Relief Of Congestion). FDA's definition for product code QZC reads: "The external mechanical stimulator for the relief of congestion delivers vibrations to the sinus and nasal areas to relieve congestion". FDA records list 2 510(k) clearances for Sound Health Systems, Inc., from to . As of , FDA records show no recalls naming DEN230045.

Clearance record

Decision date
Received
(171 days to decision)
Product code
QZC External Mechanical Stimulator For The Relief Of Congestion
Regulation
21 CFR 874.6010
Device class
Class II
Review panel
Ear, Nose, Throat
Applicant
Sound Health Systems, Inc. 650-B Fremont Ave., #363, Los Altos CA
Third party review
No

Clearances, product code QZC

Trailing 12 months

FDA records hold no clearances under product code QZC in the trailing twelve months.

FDA records show no clearances under product code QZC in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code QZC, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260