Duns Number:656002163
Device Description: The Blood Pressure Monitor LS802-B is digital monitor intended for use in measuring blood The Blood Pressure Monitor LS802-B is digital monitor intended for use in measuring blood pressure and heartbeat rate in adult patient population with arm circumference ranging from 22 cm to 42 cm (about 9 - 17 inches). This device detects the appearance of irregular heartbeats during measurement and give a warning signal with readings.The LS802-B is not intended to be a diagnostic device. Contact your physician if hypertensive values are indicated.LS802-B embed a Bluetooth module that allows it to connect with nearby BT receiving terminal.
Catalog Number
-
Brand Name
WowGoHealth
Version/Model Number
Blood Pressure Monitor LS802-B
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
May 17, 2019
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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
K131395
Product Code
DXN
Product Code Name
System, Measurement, Blood-Pressure, Non-Invasive
Public Device Record Key
04da1899-28ad-4b93-93fa-9c8fce0167d1
Public Version Date
November 08, 2019
Public Version Number
3
DI Record Publish Date
April 18, 2019
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 |
|---|---|---|
| 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 |