WowGoHealth Automatic Arm Bluetooth Blood Pressure Monitor

GUDID 34719878120037

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 with wireless communication. The devices are intended to use of Over-The-Counter.

GOLDEN SMART HOME TECHNOLOGY CORP.

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Primary Device ID34719878120037
NIH Device Record Key5fb7dc3f-350e-41b9-a441-6a9f7ac5d6a9
Commercial Distribution StatusIn Commercial Distribution
Brand NameWowGoHealth Automatic Arm Bluetooth Blood Pressure Monitor
Version Model NumberGSH862
Company DUNS656002163
Company NameGOLDEN SMART HOME TECHNOLOGY CORP.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone+88635770693
Emailservice@goldensmarthome.com.tw
Phone+88635770693
Emailservice@goldensmarthome.com.tw
Phone+88635770693
Emailservice@goldensmarthome.com.tw
Phone+88635770693
Emailservice@goldensmarthome.com.tw
Phone+88635770693
Emailservice@goldensmarthome.com.tw
Phone+88635770693
Emailservice@goldensmarthome.com.tw
Phone+88635770693
Emailservice@goldensmarthome.com.tw
Phone+88635770693
Emailservice@goldensmarthome.com.tw
Phone+88635770693
Emailservice@goldensmarthome.com.tw
Phone+88635770693
Emailservice@goldensmarthome.com.tw
Phone+88635770693
Emailservice@goldensmarthome.com.tw
Phone+88635770693
Emailservice@goldensmarthome.com.tw
Phone+88635770693
Emailservice@goldensmarthome.com.tw
Phone+88635770693
Emailservice@goldensmarthome.com.tw

Device Identifiers

Device Issuing AgencyDevice ID
GS104719878120036 [Primary]
GS134719878120037 [Package]
Contains: 04719878120036
Package: Carton [12 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DXNSystem, Measurement, Blood-Pressure, Non-Invasive

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-08-17
Device Publish Date2020-08-07

Devices Manufactured by GOLDEN SMART HOME TECHNOLOGY CORP.

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14719878122310 - WowGoHealth Bluetooth Body Fat Analyzer2021-06-01 The Body Fat Analyzer measures weight and estimate BMI and calories, and uses bio-electrical impedance analysis (BIA) technology
04719878124027 - WowGoHealth Pulse Oximeter GSH6012021-02-03 The pulse oximeter is a reusable device, and it’s intended for intermittent checks of oxygen saturation and pulse rate for adu
34719878120037 - WowGoHealth Automatic Arm Bluetooth Blood Pressure Monitor2020-08-17Automatic 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 with wireless communication. The devices are intended to use of Over-The-Counter.
34719878120037 - WowGoHealth Automatic Arm Bluetooth Blood Pressure Monitor2020-08-17 Automatic Arm Bluetooth Blood Pressure Monitor GSH862, intended to measure the systolic and diastolic blood pressure and pulse r
04719878124010 - WowGoHealth Pulse Oximeter GSH6012020-07-17 The pulse oximeter is a reusable device, and it’s intended for intermittent checks of oxygen saturation and pulse rate for adu
14719878122020 - WowGoHealth Body Fat Analyzer GSH202-B2020-04-27 The Body Fat Analyzer measures weight and estimate BMI and calories, and uses bio-electrical impedance analysis (BIA) technology
34719878120020 - WowGoHealth Blood Pressure Monitor GSH885B2019-11-08 The WowGoHealth Blood Pressure Monitor GSH885B is digital monitors intended for use in measuring blood pressure and heartbeat ra
04719878120012 - WowGoHealth2019-11-08 The Blood Pressure Monitor LS802-B is digital monitor intended for use in measuring blood pressure and heartbeat rate in adult p
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