Med-Link Reusable Blood Pressure Cuff
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K173869 FDA 510(k)
- FDA Product Code
- DXQ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.1120 FDA 510(k)
- Regulation Number
- 870.1120 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Med-Link Reusable Blood Pressure Cuff is a reusable, non-invasive blood pressure measurement accessory designed for use with automated blood pressure monitoring systems. It is classified under product code DXQ and functions as a cuff component to measure arterial blood pressure indirectly by occluding the arm and detecting pulse waves. The device is intended for repeated clinical and home use, providing accurate systolic and diastolic readings when paired with compatible monitoring devices.
This cuff is supplied in neonatal, pediatric, and adult sizes and is intended for reusable application, requiring cleaning and maintenance between uses. It is non-sterile and must be handled in accordance with facility protocols to ensure hygiene and reliability. The device received FDA 510(k) clearance under K173869, classified as substantially equivalent, and was reviewed by the Cardiovascular Advisory Committee. Storage and reuse conditions are manufacturer-specified to maintain performance and safety.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Med-link Reusable Blood Pressure Cuff by Shenzhen Med-link Electronics ..., K173869 FDA 510(k) - Med-link Reusable Blood Pressure Cuff, Med-link Reusable Blood Pressure Cuff - FDA 510(k) K173869
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K173869 | Class II | Active |
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Manufacturer
- Manufacturer
- Shenzhen Med-Link Electronics Tech Co., Ltd.
Sources (1)
- FDA 510(k) K173869 24 fields · synced Oct 1, 2026