Rossmax AE701
Device Model:
AE701
Manufacturer:
Rossmax International Ltd., 12F - 189 Kang Chien Road, Taipei 114, 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:
Discontinued but still available
Description:
The Rossmax AE701 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. This device has been discontinued by the manufacturer but may be available through certain outlets.
Assessment:
While the technology used in the Rossmax AE701, to measure blood pressure, has been declared as being equivalent to that used in a clinically validated device, no evidence has been published to show that the devices have been compared according to a protocol compliant 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 | BIHS (UK and IRL) | Self-measurement (Previous) | Manufacturer declaration of equivalence to the Rossmax ME701 |
| BP | ESH (Europe) | Self-measurement | The BIHS recommendation, despite the absence, at the time, of the scientific evidence required by the same authors' criteria. |
Device Family:
Kessler KS 551B, Rossmax AV151fB, Rossmax MW821fB, Rossmax ME701B, Rossmax Accumed AF701B, Rossmax Accumed AW150B, Rossmax AB701B, Rossmax AC701B, Rossmax AD701B, Rossmax AE701B, Rossmax AJ701B, Rossmax MA350B, Rossmax MW701f (V2)B, Rossmax MG150fB, Rossmax Accumed MH901B, Rossmax MR250B, Rossmax AK150fB, Rossmax AU941f (V1)B, Rossmax AW151B, Rossmax MH150B, Rossmax MJ150fB, Rossmax MJ701B
Legend: B BIHS Derivative
Legend: B BIHS Derivative
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.
Rossmax ME701
de Greeff A, Shennan AH. The Rossmax (ME 701 series) upper arm device: accuracy assessment in an adult population according to the International and the British Hypertension Society protocols. Blood Press Monit. 2008 Feb;13(1):43-8. doi: 10.1097/MBP.0b013e3282ca913f. PMID: 18199923.
BHS:1993 - Pass (A/A) General population
SP10:1996 - Pass General population