# K061959: Mytech / Happy Life / Maxiaids Arm Blood Pressure Monitor, HPL-301, HPL-302, HPL-310, 180310

- Pathway: 510(k) (Traditional)
- Applicant: Mytech Technology Co., Ltd.
- Decided: Aug 22, 2006 after 42 days
- Product code: DXN (System, Measurement, Blood-Pressure, Non-Invasive)
- Device class: 2
- Regulation: 21 CFR 870.1130
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K030221 (2003). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030221: Mytech / Happy Life Blood Pressure Monitor, Mytech Technology Co., Ltd. (2003) Summary page 1.

## Indications for use
The MYTECH / HAPPY LIFE / MAXIAIDS Arm Blood Pressure Monitor, Model HPL-301, HPL-302, HPL-310, 180310 are noninvasive blood pressure measurement systems intended to measure the systolic and diastolic blood pressures and pulse rate of an adult individual, over age 18, at home by using a non-invasive technique in which an inflatable cuff is wrapped around the arm. The cuff circumference is limited to be 7"-15".

Source page: https://510kreport.com/device/K061959
Methodology: https://510kreport.com/methodology