KuardioRegulatory information
Kuardio is a wellness logging app, not a medical device. It does not diagnose, treat or give medical advice. The measurement is made by the QardioArm cuff; Kuardio starts it, displays the values the cuff reports and stores them in Apple Health.
What Kuardio does
- Connects to the user's own QardioArm over the standard Bluetooth SIG Blood Pressure Profile (service 0x1810, measurement characteristic 0x2A35) and sends the cuff's start and stop command.
- Does not change the cuff, its firmware or its measurement algorithm. The cuff measures and computes the values.
- Saves blood pressure and pulse to Apple Health, and shows the user's own history, trends and a report they can share with their clinician.
- Shows optional reference categories, always attributed to their guideline (ESH 2023, ACC/AHA 2017 or NICE NG136). They can be turned off. Kuardio gives no alerts, advice or diagnosis. For very high values it only states the guideline range and suggests repeating the measurement and following the clinician's advice.
The QardioArm cuff
| USA · FDA 510(k) K140067 | QardioArm, model A100. Cleared 18 June 2014. Non-invasive blood pressure measurement system, 21 CFR 870.1130, Class II, product code DXN, over-the-counter use. Clinically validated to ANSI/AAMI ISO 81060-2:2009. Clearance and summary (PDF) · FDA database |
|---|---|
| USA · FDA 510(k) K220106 | QardioArm 2. Cleared 15 June 2022, with K140067 as predicate. Clearance and summary (PDF) · FDA database |
| EU · CE 2460 | QardioArm A100, Class IIa under the Medical Device Directive 93/42/EEC. Notified body DNV GL Nemko Presafe AS (2460). Declaration of Conformity by Qardio Netherlands B.V. (archived copy). |
The FDA 510(k) summary for K140067 says the cuff "requires an external device (e.g. a smartphone) to display results" and its indications for use state that it "is not intended to be a diagnostic device". Kuardio is that display and logging part and makes no diagnostic claims.
User manuals
Qardio's websites are going offline. Archived copies of the official QardioArm user manual (instructions for use, safety information and cuff care) are available from the Internet Archive: 2020 edition. Always follow the manual's instructions for use and safety warnings.
Not affiliated
Kuardio is independent and not affiliated with or endorsed by Qardio, Inc. The regulatory documents above belong to their owners (the FDA documents are public records) and are provided for reference only.