Identity
- Trade Name
- Wavely Ear Tip FDA UDI
- Generic Name
- Impedance audiometer FDA UDI
- Device Name
- The Wavely Ear Tip is an accessory to the Wavely Middle Ear Fluid Scanner. The Wavely 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. FDA UDI
- Model / Reference
- 1300-05 FDA UDI
- Description
- The Wavely Ear Tip is an accessory to the Wavely Middle Ear Fluid Scanner. The Wavely 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. FDA UDI
Identifiers
- Catalog Number
- 1300-05 FDA UDI
- Primary DI / UDI-DI
- 00860007953705 FDA UDI
- FDA Product Code
- PTO FDA UDI
- GMDN Term
- Impedance audiometer FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 874.1090 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Impedance audiometer
Wavely Ear Tip by Wavely Diagnostics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Wavely Diagnostics, Inc.
Sources (1)
- FDA UDI 67fef44f-0ab7-4ea9-bf7b-e30bcf1f6d8f 34 fields · synced May 30, 2026