Overview
The user manual in discussion pertains to the Withings Blood Pressure Monitor Upper Arm Type: BP-801. This medical device is designed for non-invasive blood pressure monitoring and falls under the device classification Class II, according to section 870.1130 of the CFR (Code of Federal Regulations). Withings, the manufacturer, is based in France, while the device itself is produced by YA HORNG Electronic Co., Ltd. in Taiwan.
Intended Use
The BP-801 is a cardiovascular specialty device meant to measure blood pressure non-invasively in a clinical setting or a home environment. It uses an upper arm cuff to read systolic and diastolic pressures, conveying essential information for monitoring cardiovascular health.
Comparative Analysis
The BP-801 is a legally marketed successor to the BP-800 (K10872) and the KD-936 Fully Automatic Electronic Blood Pressure Monitor (K120672). It maintains similar functionalities as these predicate devices but may include technological improvements as suggested by its distinct model number.
Contact Information
For queries and further support, the manual provides contact information. Withings can be contacted at their headquarters in France, with additional details such as their SIRET number included for reference.
Regulatory Information
This manual includes a 510(k) Summary, indicating that the device has been cleared for sale and distribution in its corresponding markets. The section includes the submitter’s name, address, and the preparation date of the summary.
Quality and Standards
The device has been categorized according to the established medical device classifications and adheres to the performance standards set forth by the relevant regulations, ensuring its quality and efficacy for its intended medical purpose.
Global Reach
With Withings based in France and manufacturer YA HORNG in Taiwan, the summary hints at a global collaboration that caters to international standards, with a reach that potentially covers various global markets.
Manual:
Download: Withings Blood Pressure Monitor Upper Arm Type: BP-801 User Manual
Chat: Powered By VoiceSphere