iHealth Track (KN-550BT)
Device Name:
Track
Device Model:
KN-550BT
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
Connected Health Technologies:
Bluetooth
Availability:
Available Currently
Availability according to Countries or Regions:
United States
Device Manual:
Click here to download the Device Manual
Description:
The iHealth Track (KN-550BT) is an automatic blood pressure monitor. Its blood pressure measurement technology has been proven to be accurate, with a 3-star Medaval rating. 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 Track (KN-550BT), to measure blood pressure, is among the best rated for accuracy by Medaval Ltd. It has passed in two clinical validation studies, between general and specific populations, according to recognised standard protocols, as published in peer-reviewed publications.
Recommendations:
Accuracy AssessmentRecommendationBasis
BP Medaval ★★★ Recommendation Recent clinical validation; recent protocol; multiple clinical validations
BP BIHS (UK and IRL) Self-measurement Manufacturer declaration of equivalence to the Andon KD-5917
BP ESH (Europe) Self-measurement The BIHS recommendation, despite the absence, at the time, of the scientific evidence required by the same authors' criteria.
BP Stride BP Self-measurement and professional use for adults and pregnancy (Preferred) Published evidence plus equivalence claim
Consumer BodyYear(s)LevelComment
BP Consumer Reports (US) Latest: 2021 Very Good
Device Family:
Andon BM-091B, Andon KD-5031D, Andon KD-556D, Andon KD-557B, Andon KD-558 (V1)B, Andon KD-5901 (V1)B, Andon KD-5902B, Andon KD-5905B, Andon KD-5909B, Andon KD-5915 (V1)B,D, Andon KD-5917B, Andon KD-5918B, Andon KD-595B, Andon KD-5961B, Andon KD-5962B, Andon KD-5965B,P, Andon KD-5913D, Andon KD-5001B, Andon KD-5963D, Andon KD-5971B,D, Andon KD-5923B,P, Andon KD-558BRP, Andon KD-5920B,P, Andon KD-5810B, Andon KD-5811B, Andon KD-5815B, Beurer BM 44D, Beurer BM 47D, Beurer BM 58D, Beurer BM 65D, Cas KD-595Z, Desa Pharma Tecnico EasyB, iHealth Track (KN-550BT)B,P, Lloyds Betterlife (KD-551)B, Lloyds KD-551B, Medel Check (92187)D, Medel Elite (92125)D, Medinox Compact (BP102, MX86005)B, Medisana BU 535 Voice (51178)Y, Medisana BU 535 (51176)Y, Medisana BU 535 Voice [S] (51179)Y, Medisana BW 335 (51077)Y, Pic Solution Digit SmartD, Pic Solution Digit ExtraD, Salter BPA-9200-GBB, Salter BPA-8200-EUB, Sanitas SBM-43D
Legend: B BIHS Derivative, D DET Equivalence, P Stride Equivalence, Y Internal declaration, Z Almost Certain
Validation Publications:

Van Den Heuvel JFM, Lely AT, Franx A, Bekker MN. Validation of the iHealth Track and Omron HEM-9210T automated blood pressure devices for use in pregnancy. Pregnancy Hypertens. 2019 Jan;15:37-41. Epub: 2018 Nov 2. doi: 10.1016/j.preghy.2018.10.008. PMID: 30825925.

ESH-IP:2010 - Pass Pregnancy (n=33), Pre-eclampsia (n=10)

Shi L, Zhang XY, Sun JY, Chen JF, Ma YF, Zhou KY. Validation of the iHealth Track upper-arm blood pressure monitor KN-550BT in general population according to the AAMI/ESH/ISO Universal Standard (ISO 81060-2:2018+AMD1:2020). Blood Press Monit. 2024 Feb 1;29(1):41-44. Epub: 2023 Sep 14. doi: 10.1097/MBP.0000000000000678 . PMID: 37702596.

81060-2:2020 - Pass General population

Relevant Publications:

Mazoteras-Pardo V, Becerro-De-Bengoa-Vallejo R, Losa-Iglesias ME, López-López D, Palomo-López P, Rodríguez-Sanz D, Calvo-Lobo C. Validation in the General Population of the iHealth Track Blood Pressure Monitor for Self-Measurement According to the European Society of Hypertension International Protocol Revision 2010: Descriptive Investigation. JMIR Mhealth Uhealth. 2019 Mar 19;7(3):e13137. doi: 10.2196/13137. PMID: 30888331. Available from: PMC6444211.

The reference device used was the Omron M3 Intellisense (HEM-7051-E). However, this is a major and fundamental violation of the protocol requirements. Despite its claims, this study is simply a comparison of two devices and cannot be considered as a validation according to the ESH-IP protocol.

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.

Andon KD-5031

Wu N, Zhang X, Wang W, Zhang H. Validation of the Andon KD5031 for clinical use and self-measurement according to the European Society of Hypertension International Protocol. Blood Press Monit. 2016 Oct;21(5):310-2. Epub: 2016 Jul 7. doi: 10.1097/MBP.0000000000000204. PMID: 27392206.

ESH-IP:2010 - Pass General population

Andon KD-5915 (V1)

Huang QF, Wang J, Sheng CS, Zhang NN, Li Y, Wang JG. Validation of the ANDON KD-5915 blood pressure monitor for home blood pressure monitoring according to the European Society of Hypertension International Protocol. Blood Press Monit. 2010 Aug;15(4):232-4. PMID: 20658765.

ESH-IP:2002 - Pass General population

Andon KD-5917

Guo WG, Li BL, He Y, Xue YS, Wang HY, Zheng QS, Xiang DC. Validation of the Andon KD-5917 automatic 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. 2014 Aug;19(4):242-5. doi: 10.1097/MBP.0000000000000048. PMID: 24847724.

ESH-IP:2010 - Pass General population

Andon KD-595

Wu N, Zhang X, Wang W, Zhang H. Validation of the Andon KD-595 for clinical use and self-measurement according to the European Society of Hypertension International Protocol. Blood Press Monit. 2016 Apr;21(2):124-7. Epub: 2015 Nov. doi: 10.1097/MBP.0000000000000164. PMID: 26544523.

ESH-IP:2010 - Pass General population

Liu K, Wu D, Bing S, Li LY. Validation of the ANDON KD-595 automated upper-arm blood pressure monitor according to the universal standard. Blood Press Monit. 2024 Apr 1;29(2):103-106. Epub: 2023 Dec 14. doi: 10.1097/MBP.0000000000000686. PMID: 38193382.

81060-2:2019 - Pass General population

Andon KD-5965

Huang J, Li Z, Li G, Liu Z. Validation of the Andon KD-5965 upper-arm blood pressure monitor for home blood pressure monitoring according to the European Society of Hypertension International Protocol revision 2010. Blood Press Monit. 2015 Oct;20(5):283-5. Epub: 2015 May 5. doi: 10.1097/MBP.0000000000000129. PMID: 25968093.

ESH-IP:2010 - Pass General population

Beurer BM 44

Lüders S, Krüger R, Zemmrich C, Forstner K, Sturm CD, Bramlage P. Validation of the Beurer BM 44 upper arm blood pressure monitor for home measurement, according to the European Society of Hypertension International Protocol 2002. Blood Press Monit. 2012 Dec;17(6):248-52. doi: 10.1097/MBP.0b013e32835b9e8e. PMID: 23147534.

ESH-IP:2002 General population (Note: ESH-02 not recognised since 01 July 2011)

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