U-RIGHT TD-3124 Blood Pressure Monitoring System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K120634 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-3124 Blood Pressure Monitoring System is an automated, upper-arm blood pressure monitor designed for measuring systolic and diastolic blood pressure, pulse rate, and irregular heartbeat detection. It falls under the category of non-invasive blood pressure measurement devices, providing quantitative readings for clinical and home use.
This system is intended for single-use or reusable application in home or professional healthcare settings, with a measurement range of 60–255 mmHg for systolic pressure, 30–195 mmHg for diastolic pressure, and 40–199 beats per minute for pulse rate. The device features a large LCD display, one-button operation, and 100 memory storage slots for patient readings. It operates via an internal power source and has been granted FDA 510(k) clearance under Special Review with a K-number of K120634.
Frequently asked questions
Can this device be used in both clinical and home settings, and how does its single-use or reusable design accommodate different environments?
Yes, the U-RIGHT TD-3124 is designed for both home and professional healthcare use. Its single-use or reusable application flexibility allows clinicians to use it in hospitals or clinics while also being practical for patients monitoring their blood pressure at home. The device’s durable construction and features like 100 memory slots for patient readings make it suitable for repeated use in clinical settings, while its simplicity and portability cater to home users.
What specific measurements does this blood pressure monitor provide, and how accurate are these readings within its stated ranges?
The U-RIGHT TD-3124 measures systolic blood pressure (60–255 mmHg), diastolic blood pressure (30–195 mmHg), and pulse rate (40–199 beats per minute). It also detects irregular heartbeats. The device’s automated, non-invasive design ensures quantitative readings within these ranges, making it reliable for clinical and home use as long as proper cuff sizing and patient positioning are followed.
How does the device’s user interface and memory function benefit clinicians or patients tracking blood pressure trends?
The device features a one-button operation and a large LCD display, simplifying use for both clinicians and patients. Its 100 memory slots allow for storing multiple readings per patient, enabling tracking of blood pressure trends over time. This is particularly useful for monitoring chronic conditions or post-treatment progress, as it eliminates the need for manual record-keeping.
Is this device powered by batteries, and if so, how does this affect its portability and convenience for home users?
Yes, the U-RIGHT TD-3124 operates via an internal power source, which likely refers to built-in batteries. This design enhances portability, allowing users to measure blood pressure without needing external power outlets. For home users, this means convenience during travel or in settings without easy access to electricity, though battery life should be checked periodically to ensure uninterrupted use.
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 TD-3124 - TaiDoc.com, PDF TD-3124_DM - TaiDoc, PDF URIGHT TD-3124B_Operation Instruction_EN_V1, TD-3124 - TaiDoc Technology - PDF Catalogs | Technical Documentation
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K120634 | Class II | Active |
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Manufacturer
- Manufacturer
- Taidoc Technology Corporation
Sources (1)
- FDA 510(k) K120634 24 fields · synced Oct 6, 2026