FDA 510(k) · Microlife Intellectual Property
K222153: Microlife Upper Arm Automatic Digital BPM, Model WatchBP Office Vascular (TWIN200 VSR) (Microlife Intellectual Property GmbH)
Microlife Intellectual Property GmbH received FDA 510(k) K222153 for Microlife Upper Arm Automatic Digital BPM, Model WatchBP Office Vascular (TWIN200 VSR), with a decision date of Feb 3, 2023 (substantially equivalent).
Prescription or OTC: Unknown (no FDA document we parsed states it).
FDA facts
| FDA number | K222153 |
|---|---|
| Pathway | 510(k) |
| Applicant | Microlife Intellectual Property GmbH |
| Device name | Microlife Upper Arm Automatic Digital BPM, Model WatchBP Office Vascular (TWIN200 VSR) |
| Product code | DXN: System, Measurement, Blood-Pressure, Non-Invasive |
| Regulation (21 CFR) | 870.1130 |
| Device class | Class 2 |
| Date received | Jul 20, 2022 |
| Decision date | Feb 3, 2023 |
| Decision | Substantially Equivalent (SESE) |
| 510(k) type | Traditional |
Source: openFDA device 510(k) data, data through Oct 26, 2026.
Indications for use parsed from FDA documents
The Microlife Upper Arm Automatic Digital Blood Pressure and Cardiovascular Screening Monitor Model WatchBP Office Vascular (TWIN200 VSR) is a non-invasive digital blood pressure device using the oscillometric technique and an upper-arm blood pressure cuff to measure systolic and diastolic blood pressures, pulse rate, mean arterial pressure (MAP) for use in adults and pediatrics (but not neonates) with arm cuff circumference sizes ranging from 14-52 cm (5.5-20.5 inches). The device can accurately measure blood pressure in pregnant patients including those with known or suspected pre- eclampsia. The device detects the appearance of atrial fibrillation during measurement and gives a warning signal together with the measured blood pressure value if atrial fibrillation is detected. The device provides aortic blood pressure parameters, including central systolic blood pressure (cSBP), central pulse pressure (cPP) and central diastolic blood pressure (cDBP), non-invasively through the use of a brachial cuff. This was validated against invasive blood pressure measurement and showed that the device determines central blood pressure measurement with high accuracy. The device provides a validated method for determining the ankle-brachial index (ABI) which may be useful in diagnosing Peripheral Artery Disease (PAD). The device is only intended to provide a numerical value of brachial-ankle pulse wave velocity (baPWV) for blood flow inside the intended blood vessel, without any diagnosis. The memory data can be transferred to the PC running the WatchBP Analyzer software by connecting the monitor via USB cable or Bluetooth. The device is intended for use by healthcare professionals in clinical practice.
Extracted automatically from FDA's 510(k) summary. It can contain extraction errors and is not a verified quote. Read the wording in the FDA PDF before relying on it.
Predicates parsed from FDA documents
FDA numbers found next to the word "predicate" in the summary. The list can include reference devices; check the PDF for which device is the primary predicate.
ChatPPG interpretation
A 510(k) decision of "substantially equivalent" means FDA found the device as safe and effective as a legally marketed predicate. FDA's word for this is cleared, not approved. The clearance covers the device and indications in this submission; it does not extend to other features or versions of the same product that were not part of it. See FDA cleared vs approved.
Product code DXN is "System, Measurement, Blood-Pressure, Non-Invasive", class 2, 21 CFR 870.1130.
Our labels for filtering: claim Blood pressure, sensor Cuff. These are heuristics, not FDA fields.