SOUND HEALTH SYSTEMS, INC.

FDA Device Registration & Listing · San Jose, CA, US · Registration 3030266327

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3030266327
FEI Number
3030266327
Entity Name
SOUND HEALTH SYSTEMS, INC.
City/State/Country
San Jose, CA, US
Establishment Address
3031 Tisch Way, 110 Plaza West, Suite #1068, San Jose, CA 95128, US
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
Sound Health Systems, Inc. (Owner Number: 10089787)
Owner / Operator Contact Address
3031 Tisch Way, 110 Plaza West, Suite #1068, San Jose, CA 95128, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K242214
PMA Number
N/A

All Registered Proprietary Names

Sonu Headband - Black (Model SHS-HW-001B) Sonu Headband - Gray (Model SHS-HW-001A)

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
QZC External Mechanical Stimulator For The Relief Of Congestion Ear, Nose, Throat Class 2 874.6010 2026-03-31

Official Correspondent

Kondapavulur Venkateswara-Rao

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Sound Health Systems, Inc.
View consolidated registration, premarket clearance, and recall records for this applicant.
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3030266327. Last updated year: 2026. Please use registration number 3030266327 when referencing this establishment in official correspondence.
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