Identity
- Trade Name
- WowGoHealth FDA UDI
- Generic Name
- Automatic-inflation electronic sphygmomanometer, portable, arm/wrist FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- Blood Pressure Monitor LS802-B FDA UDI
- Description
- 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. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04719878120012 FDA UDI
- 510(k) Number
- K131395 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
- Not 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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Dimensions & Sizes
- Size
- Height — 60 Millimeter FDA UDIWidth — 110 Millimeter FDA UDILength — 138 Millimeter FDA UDI
WowGoHealth by Golden Smart Home Technology Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K131395 also covers:
- 1BYONE — 1BYONEPRODUCTS INC.
- Easy@Home Arm Blood Pressure Monitor — EASY HEALTHCARE CORPORATION
- WowGoHealth Blood Pressure Monitor GSH885B — GOLDEN SMART HOME TECHNOLOGY CORP.
- Balance — Greater Goods, LLC
- Greater Goods — Greater Goods, LLC
- Greater Goods — Greater Goods, LLC
- Greater Goods — Greater Goods, LLC
- Greater Goods — Greater Goods, LLC
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 |
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Manufacturer
- Manufacturer
- Golden Smart Home Technology Corp.
Sources (1)
- FDA UDI 04da1899-28ad-4b93-93fa-9c8fce0167d1 38 fields · synced May 30, 2026