Device Model:
HL868BA
Manufacturer:
Health & Life Co. Ltd., 9F - 186 Jian 1st Rd., Zhonghe Dist., New Taipei City 23553, TAIWAN ROC.
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
Device Manual:
Description:
The H&L HL868BA is an automatic blood pressure monitor. Its blood pressure measurement technology has been proven to be accurate. Blood pressure measurements are taken from the upper arm. It is intended for self-measurement and home use.
Assessment:
The technology used in the H&L HL868BA, to measure blood pressure, has passed in a clinical validation study, in a general population, according to a recognised standard protocol, as published in a peer-reviewed publication.
Recommendations:
| Accuracy Assessment | Recommendation | Basis |
| BP |
Medaval |
Legacy approval |
Older clinical validation; older protocol |
| BP |
BIHS (UK and IRL) |
Self-measurement |
Published evidence |
| BP |
Stride BP |
Self-measurement for adults |
Published evidence |
Device Family:
Aspen BP-10 (BP-103H)Z,
Beurer BM 26P,
Beurer BM 40P,
Beurer BM 35/1D,P,
Braun BP-4900D,
Braun BP-5900D,
Healthcare World BP-103HZ,
H&L HL868BAB,D,
Hartmann Veroval 2-in-1 ECG (BP750X)P,
HyMark DBP-1314 (BP-103H)Z,
LotFancy BP-103HZ,
LotFancy BP-1305Z,
Proton PHCP-868BFB,
Seagull S-868BAB,
Sejoy Joytech DBP-1204 (Sejoy BP-102)F,
Sejoy Joytech DBP-1314 (Sejoy BP-103H)F,
Sejoy Joytech DBP-1209 (Sejoy BP-1209)F,
Sejoy Joytech DBP-1303 (Sejoy BP-1303)F,
Sejoy Joytech DBP-1305 (Sejoy BP-1305, Joytech DBP-1305)F,
Sejoy Joytech DBP-1307 (Sejoy BP-1307, Joytech DBP-1307)B,P,F,
Sejoy Joytech DBP-1231F,
Sejoy Joytech DBP-1332F,
Sejoy Joytech DBP-1334F,
Spengler AutoTensio Arm (SPG440)P,
Spengler Tensonic ArmP,
Xuerui XR-BP-102Z,
Xuerui XR-BP-103HZ,
Xuerui XR-BP-1209Z,
Xuerui XR-BP-1303Z,
Xuerui XR-BP-1305Z,
Xuerui XR-BP-1307ZLegend:
B BIHS Derivative,
D DET Equivalence,
P Stride Equivalence,
F FDA 510(k),
Z Almost Certain
Validation Publications:
Chen HE, Cui Y, Sheng CS, Li LH, Li Y, Wang JG. Validation of the Health & Life HL868BA blood pressure monitor for home blood pressure monitoring according to the European Society of Hypertension International Protocol. Blood Press Monit. 2008 Oct;13(5):305-8. doi: 10.1097/MBP.0b013e32830d4bd0. PMID: 18799958.
ESH-IP:2002 - Pass General population
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-1307 (Sejoy BP-1307, Joytech DBP-1307)
Lei L, Chen Y, Chen Q, Li Y, Wang JG. Validation of the SEJOY BP-1307 upper-arm blood pressure monitor for home blood pressure monitoring according to the European Society of Hypertension International Protocol revision 2010. Blood Press Monit. 2017 Dec;22(6):371-4. Epub: 2017 Aug 03. doi: 10.1097/MBP.0000000000000283. PMID: 28786853 .
ESH-IP:2010 - Pass General population
