Wrist Type Blood Pressure Monitor
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K220651 FDA 510(k)
- FDA Product Code
- DXN FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.1130 FDA 510(k)
- Regulation Number
- 870.1130 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Wrist Type Blood Pressure Monitor is a digital device designed to measure blood pressure levels. It functions as a sphygmomanometer to provide essential readings for individual health monitoring.
This device is supplied as a portable unit intended for wrist-based measurement. It has received FDA 510K clearance under the product code DXN.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Blood Pressure Monitor & Sphygmomanometer Factory | Jamr, Home Wrist Portable Blood Pressure Monitor, Wrist Blood Pressure ..., W1101L Wrist Type Blood Pressure Monitor User Manual, JAMR TECHNOLOGY W02 USER MANUAL Pdf Download | ManualsLib
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K220651 | Class II | Active |
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Manufacturer
- Manufacturer
- Shenzhen Jamr Medical Technology Co., Ltd.
Sources (1)
- FDA 510(k) K220651 24 fields · synced Oct 6, 2026