Identity
- Trade Name
- WowGoHealth Blood Pressure Monitor GSH885B FDA UDI
- Generic Name
- Automatic-inflation electronic sphygmomanometer, portable, arm/wrist FDA UDI
- Device Name
- The WowGoHealth Blood Pressure Monitor GSH885B is digital monitors intended for use in measuring blood pressure and heartbeat rate with arm circumference ranging from 22 cm to 32 cm or 22cm to 42cm. It is intended for adult indoor use only. Contraindications: 1. The device is not suitable for use on may be pregnant women or pregnant women. 2. The device is not suitable for use on patients with implanted,electrical devices, such as cardiac pacemakers, defibrillators. FDA UDI
- Model / Reference
- GSH885B FDA UDI
- Description
- The WowGoHealth Blood Pressure Monitor GSH885B is digital monitors intended for use in measuring blood pressure and heartbeat rate with arm circumference ranging from 22 cm to 32 cm or 22cm to 42cm. It is intended for adult indoor use only. Contraindications: 1. The device is not suitable for use on may be pregnant women or pregnant women. 2. The device is not suitable for use on patients with implanted,electrical devices, such as cardiac pacemakers, defibrillators. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04719878120029 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
- 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
Dimensions & Sizes
- Size
- Length — 154 Millimeter FDA UDIWidth — 106 Millimeter FDA UDIHeight — 57.1 Millimeter FDA UDI
Category: Automatic-inflation electronic sphygmomanometer, portable, arm/wrist
WowGoHealth Blood Pressure Monitor GSH885B by Golden Smart Home Technology Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
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 b347b348-ae28-41e1-8e53-335530791cd6 37 fields · synced May 31, 2026