Mytech/Happy Life Blood Pressure Monitor, Model Hpl-200
by Mytech Technology Co., Ltd.
510(k) K041228
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK041228 | Date17 May 2004 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- DXN
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.1130
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Happy Life Blood Pressure Monitor, Model HPL-200, is a non-invasive blood pressure measurement system designed to measure systolic and diastolic blood pressure, as well as pulse rate in adult individuals. Classified under the FDA’s System, Measurement, Blood-Pressure, Non-Invasive category, it adheres to regulatory standards for accurate cardiovascular monitoring. This device operates without penetrating the skin, relying on cuff-based technology to provide reliable readings. Its primary function aligns with clinical and home-use applications for tracking blood pressure trends.
This device is supplied as a reusable, non-sterile medical instrument intended for use in clinical, home, or ambulatory settings. It requires no special storage conditions beyond protection from physical damage and extreme temperatures. The cuff size must be appropriately matched to the patient’s arm circumference for accurate measurements. Authorized under FDA 510(k) clearance (K041228), the Happy Life HPL-200 falls under the Substantially Equivalent (SESE) classification, ensuring compliance with U.S. regulatory requirements for non-invasive blood pressure monitors.
Other devices from Mytech Technology Co., Ltd.
Questions
AI-generated answers, 1 Oct 2026
What is the Happy Life HPL-200 Blood Pressure Monitor used for?
The Happy Life HPL-200 is designed for non-invasive measurement of systolic and diastolic blood pressure, as well as pulse rate in adult individuals. It uses cuff-based technology to provide reliable cardiovascular readings, making it suitable for clinical, home, or ambulatory settings where ongoing blood pressure monitoring is required.
Is the Happy Life HPL-200 Blood Pressure Monitor reusable?
Yes, the Happy Life HPL-200 is supplied as a reusable device. It is classified as a non-sterile medical instrument, meaning it is intended for repeated use across multiple patients or individuals, provided proper hygiene and maintenance protocols are followed.
How should the cuff size be selected for accurate measurements?
The cuff size must be matched to the patient’s arm circumference to ensure accurate blood pressure readings. Using an incorrectly sized cuff can lead to inaccurate measurements, so it is important to select the appropriate size for the individual’s arm to maintain reliability.
What storage conditions are required for the Happy Life HPL-200?
The device does not require special storage conditions beyond protecting it from physical damage and extreme temperatures. Standard storage practices, such as keeping it in a clean, dry environment, are sufficient to maintain its functionality.
What regulatory clearance does the Happy Life HPL-200 hold?
The Happy Life HPL-200 holds FDA 510(k) clearance under the classification of Substantially Equivalent (SESE) for non-invasive blood pressure monitors. This clearance ensures compliance with U.S. regulatory standards for its intended use.