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IDOC Upper Arm Attached Blood Pressure and Pulse Rate Monitor, Model ID-42A/ID-43A

FDA 510(k)

Class II (US FDA 510(k))

510(k) K052872

by Taidoc Technology Corporation

Identifiers

510(k) Number
K052872 FDA 510(k)
FDA Product Code
DXN FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 870.1130 FDA 510(k)
Regulation Number
870.1130 FDA 510(k)
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The IDOC Upper Arm Attached Blood Pressure and Pulse Rate Monitor is a non-invasive device designed to measure blood pressure and pulse rate. It utilizes an inflatable cuff and pressure sensors to detect pulse waves via the oscillometric method, providing accurate readings for home use.

The device is supplied as a single-use or reusable unit, depending on the model, and is intended for personal use. It is not MRI safe, and storage should be in a dry, cool place away from direct sunlight. The device is regulated as a Class II medical device with special controls, and its use is authorized under FDA 510(k) clearance.

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: Idoc Upper Arm Attached Blood Pressure and Pulse Rate Monitor, Model Id ..., K052872 - IDOC UPPER ARM ATTACHED BLOOD PRESSURE ... | FDA 510(k), K052872 - IDOC UPPER ARM ATTACHED BLOOD PRESSURE ... | FDA 510(k), IDOC UPPER ARM ATTACHED BLOOD PRESSURE AND PULSE… - FDA.report

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Taidoc Technology Corporation

Sources (1)

  • FDA 510(k) K052872 24 fields · synced Oct 1, 2026