FDA.reportPublic FDA data

Sonu (Black Headband)

Primary DI
00860009781207
Brand
Sonu (Black Headband)
Company
Sound Health Systems Inc
Model
SHS-HW-001B
Device description
Sonu is indicated for the relief of moderate to severe nasal congestion due to allergic and non-allergic rhinitis. Sonu is a treatment to be used at home by individuals 22 and older.
Published
2024-03-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
QZCExternal Mechanical Stimulator For The Relief Of Congestion

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QZCExternal Mechanical Stimulator For The Relief Of CongestionEar, Nose, Throat2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
DEN230045000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
DEN230045000SonuSound Health Systems, Inc.2023-12-04QZC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10860009781204PackageGS112In Commercial Distribution
00860009781207PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1086000978120410860009781204
00860009781207008600097812078600097812070860009781207

GMDN Terms#

Term, Definition table
TermDefinition
Auditory stimulatorA mains electricity (AC-powered) device that applies sound stimuli (e.g., pure tones, speech) to a patient's acoustic system. It is typically used as a component of several types of devices such as audiometers, auditory evoked-potential recording systems, and auditory function screening devices.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
117419757
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860009781252Sonu (Gray Headband)SHS-HW-001A2024-03-09
10860009781259Sonu (Gray Headband)SHS-HW-001A2024-03-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860009781252Sonu (Gray Headband)Sound Health Systems IncQZC2024-03-09
10860009781259Sonu (Gray Headband)Sound Health Systems IncQZC2024-03-09