Motif Medical BAB0001
Device Model:
BAB0001
Manufacturer:
Brand: Motif Medical LLC, Suite 550, 2626 Glenwood Avenue, Raleigh, NC 27608, UNITED STATES.
Measuring functions:
Blood Pressure and PR
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
Description:
The Motif Medical BAB0001 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 Motif Medical BAB0001, 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 Stride BP Self-measurement for adults (Preferred) Equivalence to the Sejoy Joytech DBP-6279B claim without published evidence
BP AMA VDL (US) Self-measurement for adults A validation, without a reference, which Medaval is unable to identify.
Device Family:
Aposán DBP-6194P, Motif Medical BAB0001P, Sejoy Joytech DBP-6179P, Sejoy Joytech DBP-6191P, Sejoy Joytech DBP-6192P, Sejoy Joytech DBP-6279BP, Sejoy Joytech DBP-6191HDP, Sejoy Joytech DBP-6282BP, Sejoy Joytech DBP-6285BP
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.

Sejoy Joytech DBP-6279B

Duan B, He L, Zhang J, Fang L, Li G. Validation of the JOYTECH DBP-6279B blood pressure monitor in adults and adolescents according to the AAMI/ESH/ISO universal standard(ISO 81060-2:2018 + Amd.1:2020). Blood Press Monit. 2023 Oct 1;28(5):284-288. Epub: 2023 Jul 12. doi: 10.1097/MBP.0000000000000662. PMID: 37434533. Available from: PMC10484188.

81060-2:2018/Amd 1:2020 - Pass General population

Yang R, Li F. Validation of the DBP-6279B arm-type fully automatic digital blood pressure monitor in pregnancy according to the ISO 81060-2:2018/AMD 1:2020 protocol. Blood Press Monit. Epub: 2025 Nov 6. doi: 10.1097/MBP.0000000000000779. PMID: 41190939.

81060-2:2018/Amd 1:2020 - Pass Pregnancy

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