← Back to catalogue
WowGoHealth Automatic Arm Bluetooth Blood Pressure Monitor
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- WowGoHealth Automatic Arm Bluetooth Blood Pressure Monitor FDA UDI
- Generic Name
- Automatic-inflation electronic sphygmomanometer, portable, arm/wrist FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- GSH862 FDA UDI
- 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. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04719878120036 FDA UDI
- 510(k) Number
- K161846 FDA UDI
- FDA Product Code
- DXN FDA UDI
- GMDN Term
- Automatic-inflation electronic sphygmomanometer, portable, arm/wrist FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1130 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Automatic-inflation electronic sphygmomanometer, portable, arm/wrist
WowGoHealth Automatic Arm Bluetooth Blood Pressure Monitor by Golden Smart Home Technology Corp. — Class II — FDA UDI — listed in FDA GUDID
Similar devices
Also classified as Automatic-inflation electronic sphygmomanometer, portable, arm/wrist.
- Arm Type Automatic Blood Pressure Monitor — Shenzhen Jiacom Technology Co., Ltd · Class II
- Dario Smart Monitor (Cellular) - Blood Pressure Monitoring System — DARIOHEALTH CORP. · Class II
- MoDash — Shenzhen Urion Technology Co., Ltd. · Class II
- Veridian Healthcare — VERIDIAN HEALTHCARE · Class II
- Welch Allyn, Inc. — Welch Allyn, Inc. · Class II
- BRIGHT LIFE — Shenzhen Urion Technology Co., Ltd. · Class II
- RemoteCare 4U — Guangdong Transtek Medical Electronics Co., Ltd · Class II
- Omron 3 Series Upper Arm Blood Pressure Monitor — Omron Healthcare, Inc. · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Golden Smart Home Technology Corp.
Sources (1)
- FDA UDI 5fb7dc3f-350e-41b9-a441-6a9f7ac5d6a9 35 fields · synced Jun 8, 2026