| Primary Device ID | 34719878120037 |
| NIH Device Record Key | 5fb7dc3f-350e-41b9-a441-6a9f7ac5d6a9 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | WowGoHealth Automatic Arm Bluetooth Blood Pressure Monitor |
| Version Model Number | GSH862 |
| Company DUNS | 656002163 |
| Company Name | GOLDEN SMART HOME TECHNOLOGY CORP. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | true |
| 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 | 2020-08-17Automatic 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 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 | 2019-11-08 The Blood Pressure Monitor LS802-B is digital monitor intended for use in measuring blood pressure and heartbeat rate in adult p |