WavelyDx Middle Ear Fluid CMD iOS Application

Primary DI
00860007953767
Brand
WavelyDx Middle Ear Fluid CMD iOS Application
Company
Wavely Diagnostics, Inc.
Model
SWA-1488
Catalog number
SWA-1488
Device description
The WavelyDx Middle Ear Fluid Scanner utilizes the WavelyDx Middle Ear Fluid CMD iOS Application, the mobile software, in conjunction with the WavelyDx Ear Tip accessory. The WavelyDx Middle Ear Fluid Scanner turns a smartphone into an acoustic reflectometer, which uses sound waves to accurately detect the presence of middle ear fluid that may be associated with acute ear infection.
Published
2026-04-03
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
PTOTester, Auditory Impedance, Exempt

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PTOTester, Auditory Impedance, ExemptEar, Nose, Throat2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860007953767PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860007953767008600079537678600079537670860007953767

GMDN Terms#

Term, Definition table
TermDefinition
Impedance audiometerAn electronic instrument used to evaluate the functional condition of the middle ear by changing the air pressure in the external auditory canal to measure and graph the mobility characteristics of the tympanic membrane. It identifies abnormalities in tympanic membrane mobility due to stiffness, flaccidity, or the presence of fluid in the middle ear cavity. The device is also used to measure the acoustic reflex threshold from contractions of the stapedial muscle, to monitor healing of tympanic membrane grafts or stapedectomies, or to monitor follow up treatment for inflammation of the middle ear.

Regulatory Flags#

DUNS number
116723050
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860007953736WavelyDx Ear Tip - Pack of 31480-031480-032026-04-03
00860007953774WavelyDx Ear Tip - Pack of 61480-061480-062026-04-03
00860007953781WavelyDx Ear Tip - Pack of 21538-021538-022026-04-03
00860007953705Wavely Ear Tip1300-051300-052022-08-08
00860007953712WavelyDx Middle Ear Fluid CMD iOS ApplicationSWA-1262SWA-12622022-08-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08054187381232easyTympINVENTIS SRLPTO2026-04-23
08054187381249easyTymp Docking StationINVENTIS SRLPTO2026-04-23
00860007953736WavelyDx Ear Tip - Pack of 3Wavely Diagnostics, Inc.PTO2026-04-03
00860007953774WavelyDx Ear Tip - Pack of 6Wavely Diagnostics, Inc.PTO2026-04-03
00860007953781WavelyDx Ear Tip - Pack of 2Wavely Diagnostics, Inc.PTO2026-04-03
08054187380761TIMPANI DOCKING STATIONINVENTIS SRLPTO2023-01-04
00860007953705Wavely Ear TipWavely Diagnostics, Inc.PTO2022-08-08
00860007953712WavelyDx Middle Ear Fluid CMD iOS ApplicationWavely Diagnostics, Inc.PTO2022-08-08
08054187380747TIMPANIINVENTIS SRLPTO2019-04-16
08054187380259FLUTEINVENTIS SRLPTO2016-09-17
08054187380266FLUTEINVENTIS SRLPTO2016-09-17
08054187380273FLUTEINVENTIS SRLPTO2016-09-17
08054187380280FLUTEINVENTIS SRLPTO2016-09-17
08054187380440FLUTEINVENTIS SRLPTO2016-09-17
08054187380457FLUTEINVENTIS SRLPTO2016-09-17
08054187380464CLARINETINVENTIS SRLPTO2016-09-17
08054187380471CLARINETINVENTIS SRLPTO2016-09-17
08054187380488CLARINETINVENTIS SRLPTO2016-09-17
08054187380495CLARINETINVENTIS SRLPTO2016-09-17
08054187380402VIOLAINVENTIS SRLPTO2016-09-17
08054187380419VIOLAINVENTIS SRLPTO2016-09-17
08054187380426VIOLAINVENTIS SRLPTO2016-09-17
08054187380433VIOLAINVENTIS SRLPTO2016-09-17