iHealth Clear (BPM1)

Device Name:

Clear (BPM1)

Manufacturer:

OBL: iHealthlabs Europe SAS, 36 Rue de Ponthieu, 75008 Paris, FRANCE.

OEM: Andon Health Co. Ltd., 3 Jinping Road, Ya'an Street, Nankai District, Tianjin 300190, CHINA.

Measuring functions:

Blood pressure

Primary Client Use:

Intended for self-measurement and home use

Measurement Site:

Upper Arm

Measurement Occurrence:

Single measurements only

Availability:

Available Currently

Availability according to Countries or Regions:

United States

Device Manual:

Click here to download the Device Manual

Description:

The iHealth Clear (BPM1) is an automatic blood pressure monitor. The accuracy of its blood pressure measurement technology has yet to be proven to MDR requirements. Blood pressure measurements are taken from the upper arm. It is intended for self-measurement and home use.

Assessment:

The technology used in the iHealth Clear (BPM1), to measure blood pressure, has been compared to a clinically validated device, but the results of the equivalence study have not been published and cannot be verified; nor can the protocol be checked for compliance with (EU) 2017/745 and MEDDEV 2.7/1 rev 4.

Recommendations:

	Accuracy Assessment	Recommendation	Basis
BP	Medaval	None	Although equivalence to another device is claimed, this has not been tested to MDR requirements.
BP	Stride BP	Self-measurement and professional use for adults (Preferred)	Equivalence claim without published evidence

	Consumer Body	Year(s)	Level	Comment
BP	Consumer Reports (US)	Latest: 2018-2021	Very Good

Device Family:

iHealth BP3 (KD-931)P, iHealth Clear (BPM1)P
Legend: P Stride Equivalence

Validation Publications for Equivalent Devices:

Note: This is a provisional list, as equivalence according to EU Regulation 2017/745 (e.g. MEDDEV 2.7/1 rev 4) is not proven. Accordingly, these publications are not used in the assessment of star-ratings.

iHealth BP3 (KD-931)

Chen C, Shang F, Wang J, Chen J, Ji N, Wan Y. Validation of the iHealth BP3 upper-arm blood pressure monitor, for clinic use and self-measurement, according to the European Society of Hypertension International Protocol revision 2010. Blood Press Monit. 2012 Dec;17(6):253-6. doi: 10.1097/MBP.0b013e32835b9ecb. PMID: 23147535.

ESH-IP:2010 - Pass General population