☰
🏠
📞  +353 1 6643768
 
📧  info@medaval.ie
      
InBody BP170B
Device Model:
BP170B
Manufacturer:
InBody Co. Ltd., InBody Building, 54 Nonhyeon-ro 2-gil, Gangnam-gu, Seoul 06313, REPUBLIC of KOREA.
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:
Canada
Description:
The InBody BP170B 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 InBody BP170B, 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 AssessmentRecommendationBasis
BP Medaval None Although equivalence to another device is claimed, this has not been tested to MDR requirements.
BP Hypertension Canada Self-measurement (Previous) (Gold) Manufacturer declaration of equivalence
BP Stride BP Self-measurement for adults (Preferred) Equivalence claim without published evidence
Device Family:
InBody BP170P, InBody BP170BP, KOROT P3 Accurate (InBody BPBIO480KV)F
Legend: P Stride Equivalence, F FDA 510(k)
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.

InBody BP170

Kollias A, Anagnostopoulos I, Gravvani A, Stambolliu E, Bountzona I, Menti A, Stergiou GS. Validation of the InBody BP170 oscillometric home blood pressure monitor in general population according to the Association for the Advancement of Medical Instrumentation/European Society of Hypertension/International Organization for Standardization Universal Standard. Blood Press Monit. 2020 Feb;25(1):50-52. Epub: 2019 Oct 15. doi: 10.1097/MBP.0000000000000410. PMID: 31633518.

81060-2:2019 - Pass General population

KOROT P3 Accurate (InBody BPBIO480KV)

Ntineri A, Theodosiadi A, Menti A, Kyriakoulis KG, Ntousopoulos V, Kollias A, Stergiou GS. A novel professional automated auscultatory blood pressure monitor with visual display of Korotkoff sounds: InBody BPBIO480KV validation according to the Association for the Advancement of Medical Instrumentation/European Society of Hypertension/International Organization for Standardization Universal Standard. J Hypertens. 2023 Feb 1;41(2):356-361. Epub: 2022 Dec 14. doi: 10.1097/HJH.0000000000003341.. PMID: 36524556.

81060-2:2019 - Pass General population

Fania C, Giletto A, Niero A, Palatini P. Accuracy of the KOROT P3 Accurate automated auscultatory blood pressure measuring device for professional use in people with extra-large arms. Blood Press Monit. 2024 Jun 1;29(3):144-148. Epub: 2024 Feb 23. doi: 10.1097/MBP.0000000000000696. PMID: 38390635.

81060-2:2019 - Pass Extra-Large arms

EN ISO 81060-2 special patient population (37 participants).

© Medaval Ltd. Please read the Terms and Conditions before using this site.