Duns Number:656002163
Device Description: Automatic Arm Bluetooth Blood Pressure Monitor GSH862, intended to measure the systolic an Automatic Arm Bluetooth Blood Pressure Monitor GSH862, intended to measure the systolic and diastolic blood pressure and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm.The devices’ features include irregular pulse rhythm detection during measurement, and will display a alert signal with the reading when irregular heartbeat is detected.The devices’ feature include Bluetooth function to transmit data to an external Bluetooth device withwireless communication.The devices are intended to use of Over-The-Counter.
Catalog Number
-
Brand Name
WowGoHealth Automatic Arm Bluetooth Blood Pressure Monitor
Version/Model Number
GSH862
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
K161846,K161846
Product Code
DXN
Product Code Name
System, Measurement, Blood-Pressure, Non-Invasive
Public Device Record Key
5fb7dc3f-350e-41b9-a441-6a9f7ac5d6a9
Public Version Date
August 17, 2020
Public Version Number
1
DI Record Publish Date
August 07, 2020
Package DI Number
34719878120037
Quantity per Package
12
Contains DI Package
04719878120036
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 5 |