The device has received FDA 510(k) clearance and is officially listed in the FDA Device Registration and Listing database. Cleared under Product Code DXN as a Noninvasive Blood Pressure Measurement System. ZYBS Consulting LLC is registered as the U.S. distributor (OO# 10093047).
"FDA 510(k) Cleared" — not "FDA Approved." These are legally distinct designations.
ZYBS Consulting LLC is a registered medical device establishment with the FDA Center for Devices and Radiological Health (CDRH), Division 2 Establishment Support.
Registered as: ZYBS Consulting LLC DBA ZYBS Medical, DBA ZYBS Medical Device
Regulated as a Class II medical device under 21 CFR 870.1130. Class II devices require general controls and special controls to provide reasonable assurance of safety and effectiveness.
Product Code: DXN — Noninvasive Blood Pressure Measurement System
Uses the oscillometric method — the same technology used in hospital-grade automated blood pressure devices — to detect arterial wall oscillations and calculate systolic and diastolic pressure.
Dedicated blood pressure chip reduces signal noise vs. general-purpose sensors.
All marketing materials comply with FDA 21 CFR Part 801 labeling requirements. No unauthorized clinical claims are made. The device is marketed as "FDA 510(k) Cleared" — not "FDA Approved."
No "miracle cure" or unauthorized clinical efficacy claims are used in any materials.
This device is intended for home use by adults for noninvasive blood pressure measurement. It is not intended to diagnose, treat, cure, or prevent any disease.
Clinical decisions should be made by a licensed healthcare provider.
