Duns Number:131229197
Device Description: The Tranquil II OTE utilizes advanced digital signal processing with broadband white or pi The Tranquil II OTE utilizes advanced digital signal processing with broadband white or pink noise integrated into a cosmetically appealing mini OTE case design. Designed for patients that suffer from Tinnitus
Catalog Number
-
Brand Name
Tranquil II OTE
Version/Model Number
Tranquil II,OTE,10A,Digital,Grey,Pair
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K061459
Product Code
KLW
Product Code Name
Masker, Tinnitus
Public Device Record Key
b29ad66b-bbb6-4e4b-8bc0-0d45ba9beb96
Public Version Date
August 05, 2022
Public Version Number
4
DI Record Publish Date
September 28, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 60 |