Arm Blood Pressure Monitor, Model KP-7600
510(k) K061760
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK061760 | Date14 Aug 2006 | 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- Withdrawn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, 18 Sep 2026
This device is a non-invasive blood pressure measurement system, classified under the FDA’s classification name System, Measurement, Blood-Pressure. It measures systolic and diastolic blood pressure and pulse rate using an inflatable cuff wrapped around the upper arm, combined with a semiconductor sensor and internal air pump for automated readings. The monitor provides digital output via a dot-matrix LCD display, ensuring accurate and user-friendly assessment of cardiovascular parameters.
The Arm Blood Pressure Monitor, Model KP-7600, is operated manually via control keys and powered by either battery or AC/DC sources. It is intended for single-use or reusable clinical or home settings, with no explicit sterility requirements stated. The device holds FDA 510(k) clearance under the Substantially Equivalent determination (K061760, Product Code DXN) and adheres to regulatory standards for cardiovascular measurement systems. Storage conditions are not specified in the available data.
Other devices from K-jump Health Co., Ltd.
Questions
AI-generated answers, 18 Sep 2026
What types of settings can the KP-7600 be used in, and how is it powered?
The KP-7600 is designed for both clinical and home use, offering flexibility for single-use or reusable applications. It operates manually via control keys and can be powered by either batteries or an AC/DC power source, making it adaptable to different environments without requiring a fixed electrical outlet.
How does the KP-7600 display its readings, and what cardiovascular metrics does it measure?
The KP-7600 uses a dot-matrix LCD display to show its readings clearly. It measures systolic and diastolic blood pressure as well as pulse rate, providing a comprehensive assessment of cardiovascular parameters in an automated and user-friendly format.
Is the KP-7600 approved for use in the U.S., and what regulatory pathway was followed?
Yes, the KP-7600 holds FDA 510(k) clearance under the Substantially Equivalent determination (K061760) for blood pressure measurement systems. It was reviewed by the Cardiovascular (CV) Advisory Committee and classified under Product Code DXN, ensuring compliance with U.S. regulatory standards for non-invasive blood pressure monitors.
What size cuff does the KP-7600 use, and is it suitable for a wide range of arm sizes?
The KP-7600 uses an inflatable cuff designed for upper-arm measurements. While the exact size range isn’t specified in the data, its classification as an arm blood pressure monitor implies it is intended for standard adult arm circumferences, though users should verify fit for their specific needs.
Are there any special storage requirements for the KP-7600, or can it be stored under typical conditions?
The available data does not specify any special storage conditions for the KP-7600. However, since it is intended for reusable use, it should be stored in a clean, dry environment away from direct sunlight or extreme temperatures to maintain its functionality and hygiene.