Health Check Kiosk
by Xperex Corporation 510(k)
Active
510(k) K063008
Overview
The Health Check Kiosk is a multi-functional device designed to measure personal health parameters such as weight, body fat, blood pressure, and pulse rate. It is intended for use in public or non-medical settings, including gyms, offices, and retail environments, allowing the general public to self-measure their health metrics.
The device is supplied as a self-contained unit and is intended for informational purposes only, not for diagnostic use. It is not reusable and must be used in accordance with the manufacturer's instructions. The device is regulated as a Class II medical device under FDA 510(k) clearance (K063008).
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK063008 | Date7 Jun 2007 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
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
Questions
What health parameters can the Health Check Kiosk measure?
The device is designed to measure personal health metrics including weight, body fat percentage, blood pressure, and pulse rate.
Is the Health Check Kiosk intended for diagnostic use?
No, it is intended for informational purposes only and is not for diagnostic use.
Where can the Health Check Kiosk be used?
It is intended for use in public or non-medical settings such as gyms, offices, and retail environments.
Is the Health Check Kiosk reusable?
No, the device is not reusable and must be used in accordance with the manufacturer's instructions.