MS1

Organization name

Movesense Ltd

SRN

FI-MF-000024281

Manufacturer status

Active

3 warnings recorded — scroll inside the panel to see all entries.

• CW011

  Movesense MD shall not be used as a primary monitoring device for vital physiological parameters (such as ECG, heart rate, respiratory rate) in clinical situations where the patient is in an immediate danger, such as during intensive care.
• CW010

  Movesense MD shall not be used as a life sustaining or life supporting device.
• CW018

  Movesense MD may not be used to measure ECG from infants weighing less than 10kg. There is no weight limit for the patients whose motion is measured.

Primary placement in Finland; available across 32 countries total.

Trade name

not provided

UDI-DI code

06429810883001

Basic UDI-DI

64298108830016K

Reference / catalog number

MS1

Issuing entity

GS1

Risk category

Class IIa

Applicable legislation

MDR [Regulation (EU) 2017/745 on medical devices]

Status

On the market

Quantity

1

Additional product description

Movesense MD sensor is a wearable and portable medical device and is intended for measuring single channel ambulatory ECG for the investigation of the human heart, and to provide precise quantitative measurement of human movement, enabling tracking of the effects of body condition, disease or injury through their influence on the movement system. Movesense MD provides an optional ECG R-peak detection and physiological parameter analysis of ECG data, such as HRV (Heart Rate Variability) and HR (Heart Rate). Device ECG functionality is intended to be used by home and professional users for patients with bodyweight of 10 kg or more, whereas the movement measurement functionality has no limitations. Device allows third party manufacturers to access and further process the measured data and data analyses via third party developed custom software, according to their intended purpose.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

• C900399CARDIOVASCULAR SENSORS - OTHER

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification