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510(k) Data Aggregation
(174 days)
The cuff is compatible with non-invasive blood pressure monitors to measure blood pressure.
It is intended for use by healthcare professionals (prescription use) and by laypersons in home settings (over-the-counter use).
The cuff is designed for adult patients. It is non-sterile and reusable.
The primary components of the AViTA blood pressure cuff include an inflatable bladder and an outer fabric layer with a hook-and-loop fastening system. The cuff is designed to wrap securely around the patient's upper arm, allowing for accurate measurement of blood pressure when used with AViTA blood pressure monitors.
The AViTA blood pressure cuffs are available in five different sizes to accommodate a range of arm circumferences:
| Model | Limb Range (Unit: cm) |
|---|---|
| 6NRUI-K | 22-42 cm |
| 6NRLI-K | 33-42 cm |
| 6NRXI-K | 42-52 cm |
| 6NRSI-K | 15-22 cm |
| 6NRMI-K | 22-33 cm |
During operation, the cuff inflates and deflates to occlude and release arterial blood flow, utilizing the oscillometric method to detect systolic and diastolic pressure. The cuff is constructed with durable materials to withstand repeated inflation cycles and ensure long-term performance.
The AViTA blood pressure cuff is designed for compatibility with AViTA blood pressure monitors, ensuring optimal performance and measurement accuracy.
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