Wrist Electronic Sphygmomanometer
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K193386 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)
This device is a wrist electronic sphygmomanometer, classified under the FDA’s product code DXN (Noninvasive Blood Pressure Measuring Device). It measures arterial blood pressure non-invasively by detecting pulse waves in the wrist, providing systolic and diastolic readings via an electronic display. The device is designed for clinical and home use to monitor blood pressure efficiently.
The Wrist Electronic Sphygmomanometer is supplied as a single-use or reusable device (as specified by the manufacturer) and is intended for use in clinical settings, patient homes, or ambulatory care. It operates on battery power and includes an LED display for readability. The device complies with FDA 510(k) clearance (K193386) and MDD (Medical Device Directive) requirements, ensuring regulatory adherence for blood pressure measurement applications. No specific sterility or MRI safety information is provided in the data.
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: Wrist Electronic Sphygmomanometer (K193386) — FDA 510(k) | Innolitics, Shenzhen Changkun Technology Co., Ltd., Buy Shenzhen Changkun Technology Co Ltd Wrist Blood Pressure Monitors ...
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K193386 | Class II | Active |
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Manufacturer
- Manufacturer
- Shenzhen Changkun Technology Co., Ltd.
Sources (2)
- FDA 510(k) K193386 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 18, 2026