U-RIGHT TD-3128 Blood Pressure Monitoring System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K112216 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 U-RIGHT TD-3128 Blood Pressure Monitoring System is a device used for measuring blood pressure. It is designed to provide accurate blood pressure readings for monitoring purposes.
This system is supplied by Taidoc Technology Corporation and has received FDA 510(k) clearance with the product code DXN. It is intended for use in settings where blood pressure monitoring is required, though specific sterility, single-use or reusable status, MRI safety, and storage details are not provided in the available data.
Frequently asked questions
What is the U-RIGHT TD-3128 Blood Pressure Monitoring System used for?
The U-RIGHT TD-3128 Blood Pressure Monitoring System is designed to provide accurate blood pressure readings for monitoring purposes in settings where blood pressure monitoring is required.
What regulatory approvals does the U-RIGHT TD-3128 Blood Pressure Monitoring System have?
The U-RIGHT TD-3128 Blood Pressure Monitoring System has received FDA 510(k) clearance with the product code DXN. It was determined to be substantially equivalent by the Cardiovascular advisory committee.
Is the U-RIGHT TD-3128 Blood Pressure Monitoring System single-use or reusable?
The available data does not specify whether the U-RIGHT TD-3128 Blood Pressure Monitoring System is single-use or reusable. Similarly, information about sterility, MRI safety, and storage details are not provided in the available data.
Who manufactures the U-RIGHT TD-3128 Blood Pressure Monitoring System?
The U-RIGHT TD-3128 Blood Pressure Monitoring System is supplied by Taidoc Technology Corporation, located in New Taipei City, Taiwan. The contact person is Linda Ko.
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.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K112216 | Class II | Active |
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Manufacturer
- Manufacturer
- Taidoc Technology Corporation
Sources (1)
- FDA 510(k) K112216 24 fields · synced Oct 6, 2026