Duns Number:021217115
Device Description: Pulse by EHE Health (“Pulse”) is a Software as a Medical Device (SaMD) intended to be used Pulse by EHE Health (“Pulse”) is a Software as a Medical Device (SaMD) intended to be used by healthcare providers (HCPs) and their patients – aged 18 years and older – who have type 1 or type 2 diabetes. Pulse is intended to assist patients in managing their diabetes with guidance from their providers.
Catalog Number
-
Brand Name
Pulse by EHE Health
Version/Model Number
v1.0
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
Yes
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
K190013
Product Code
MRZ
Product Code Name
Accessories, Pump, Infusion
Public Device Record Key
75e75793-fae0-4214-ba9c-4abf1ec8f78a
Public Version Date
October 24, 2022
Public Version Number
2
DI Record Publish Date
May 02, 2022
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. | 56 |