WowGoHealth

GUDID 04719878120012

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.

GOLDEN SMART HOME TECHNOLOGY CORP.

Automatic-inflation electronic sphygmomanometer, portable, arm/wrist

• Primary Device ID: 04719878120012
• NIH Device Record Key: 04da1899-28ad-4b93-93fa-9c8fce0167d1
• Commercial Distribution Discontinuation: 2019-05-17
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: WowGoHealth
• Version Model Number: Blood Pressure Monitor LS802-B
• Company DUNS: 656002163
• Company Name: GOLDEN SMART HOME TECHNOLOGY CORP.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: +88635770693
• Email: service@goldensmarthome.com.tw

Device Dimensions

• Length: 138 Millimeter

Operating and Storage Conditions

• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	04719878120012 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131395

FDA Product Code

• DXN: System, Measurement, Blood-Pressure, Non-Invasive

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-11-08
• Device Publish Date: 2019-04-18

Devices Manufactured by GOLDEN SMART HOME TECHNOLOGY CORP.

• 04719878123518 - WowGoHealth Infrared Ear & Forehead Thermometer GSH-351: 2023-04-05 The WowGoHealth Infrared Ear & Forehead Thermometer (Model GSH-351) is an infrared thermometer intended for the intermittent mea
• 14719878122310 - WowGoHealth Bluetooth Body Fat Analyzer: 2021-06-01 The Body Fat Analyzer measures weight and estimate BMI and calories, and uses bio-electrical impedance analysis (BIA) technology
• 04719878124027 - WowGoHealth Pulse Oximeter GSH601: 2021-02-03 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 Monitor: 2020-08-17 Automatic Arm Bluetooth Blood Pressure Monitor GSH862, intended to measure the systolic and diastolic blood pressure and pulse r
• 04719878124010 - WowGoHealth Pulse Oximeter GSH601: 2020-07-17 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-B: 2020-04-27 The Body Fat Analyzer measures weight and estimate BMI and calories, and uses bio-electrical impedance analysis (BIA) technology
• 34719878120020 - WowGoHealth Blood Pressure Monitor GSH885B: 2019-11-08 The WowGoHealth Blood Pressure Monitor GSH885B is digital monitors intended for use in measuring blood pressure and heartbeat ra
• 04719878120012 - WowGoHealth: 2019-11-08The 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.
• 04719878120012 - WowGoHealth: 2019-11-08 The Blood Pressure Monitor LS802-B is digital monitor intended for use in measuring blood pressure and heartbeat rate in adult p