Duns Number:829477228
Device Description: The Zzoma Positional Device is an FDA-cleared positional medical device for the treatment The Zzoma Positional Device is an FDA-cleared positional medical device for the treatment of mild to moderate positional Obstructive Sleep Apnea (OSA).
Catalog Number
-
Brand Name
Zzoma
Version/Model Number
001
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
K100160
Product Code
MYB
Product Code Name
Pillow,Cervical(For Mild Sleep Apnea)
Public Device Record Key
4d3454d1-dca1-4183-b9da-76776edf2e0e
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
November 11, 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. | 1 |