Duns Number:600025387
Device Description: RESPeRATE lowers blood pressure by relaxing constricted blood vessels which cause high blo RESPeRATE lowers blood pressure by relaxing constricted blood vessels which cause high blood pressure. RESPeRATE does so by harnessing the therapeutic power of slow-paced breathing with prolonged exhalation in a way that is virtually impossible to achieve on your own. All you have to do is breathe along with RESPeRATE’s guiding tones.
Catalog Number
-
Brand Name
RESPeRATE
Version/Model Number
ULTRA
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)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K020399
Product Code
HCC
Product Code Name
Device, Biofeedback
Public Device Record Key
2c50f1af-7a03-4903-8e05-b3f622add566
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
November 19, 2017
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. | 2 |