FDA.reportPublic FDA data

WowGoHealth Automatic Arm Bluetooth Blood Pressure Monitor

Primary DI
34719878120037
Brand
WowGoHealth Automatic Arm Bluetooth Blood Pressure Monitor
Company
GOLDEN SMART HOME TECHNOLOGY CORP.
Model
GSH862
Device description
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.
Published
2020-08-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
DXNSystem, Measurement, Blood-Pressure, Non-Invasive

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DXNSystem, Measurement, Blood-Pressure, Non-InvasiveCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K161846000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K161846000Automatic Arm Bluetooth Blood Pressure MonitorTruly Instrument Limited2016-10-24DXN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
34719878120037PackageGS112In Commercial Distribution
04719878120036PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
3471987812003734719878120037
04719878120036047198781200364719878120036

GMDN Terms#

Term, Definition table
TermDefinition
Automatic-inflation electronic sphygmomanometer, portable, arm/wristAn electrically-powered device designed to noninvasively measure blood pressure using a self-contained software program that regulates automatic arm/wrist-cuff inflation and measurement cycles. It typically displays current heart rate and mean arterial pressure in addition to systolic and diastolic blood pressures; it may have memory to store blood pressure values and may sound an alarm if blood pressure exceeds pre-set limits. This device is designed to be portable (e.g., hand-held or carried in a pouch) and is often used for emergency services or home blood pressure monitoring.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+88635770693service@goldensmarthome.com.tw

Regulatory Flags#

DUNS number
656002163
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04719878121125WowGoHealth Blood Glucose Test Strips - GSH-BGM902 - 2*25GSH-BGM902 - 2*252019-07-04
04719878123518WowGoHealth Infrared Ear & Forehead Thermometer GSH-351GSH-3512023-03-28
04719878124027WowGoHealth Pulse Oximeter GSH601GSH601Orange2021-01-26
04719878124010WowGoHealth Pulse Oximeter GSH601GSH601Gray2020-07-09
04719878122313WowGoHealth Bluetooth Body Fat AnalyzerGSH231 (A3K)2021-05-24
14719878122310WowGoHealth Bluetooth Body Fat AnalyzerGSH231 (A3K)2021-05-24
04719878120036WowGoHealth Automatic Arm Bluetooth Blood Pressure MonitorGSH8622020-08-07
04719878122023WowGoHealth Body Fat Analyzer GSH202-BGSH202-B2020-04-19
14719878122020WowGoHealth Body Fat Analyzer GSH202-BGSH202-B2020-04-19
04719878120029WowGoHealth Blood Pressure Monitor GSH885BGSH885B2019-05-17
34719878120020WowGoHealth Blood Pressure Monitor GSH885BGSH885B2019-05-17
04719878120012WowGoHealthBlood Pressure Monitor LS802-B2019-04-18
04719878123013WowGoHealth IR Ear Thermometer with Bluetooth GSH-BTS301GSH-BTS3012019-07-12
04719878121019WowGoHealth Blood Glucose Monitoring System GSH-BGM902GSH-BGM9022019-07-04
04719878121156WowGoHealth Control Solution - GSH-BGM902 - Level 1GSH-BGM902 - Level 12019-07-04

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