FDA UDI
In Commercial Distribution
🇺🇸 United States
WavelyDx Middle Ear Fluid CMD iOS Application
DI: 00860007953767
·
Model: SWA-1488
·
Wavely Diagnostics, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- WavelyDx Middle Ear Fluid CMD iOS Application
- Primary DI
- 00860007953767
- Version / Model
- SWA-1488
- Catalog Number
- SWA-1488
- Company Name
- Wavely Diagnostics, Inc.
- Labeler DUNS
- 116723050
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-04-03
- Public Version
- 1
- Public Version Date
- 2026-04-13
- Public Version Status
- New
- Public Device Record Key
- 4a8f0d1b-64fb-4ae9-9dca-4c8dd036d202
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.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| PTO | Tester, Auditory Impedance, Exempt | Ear, Nose, Throat | 874.1090 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36717 | Impedance audiometer | An 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00860007953767 | GS1 |