Visomat Comfort Form (24035) (v1)
Device Name:
Comfort Form
Device Model:
24035
Manufacturer:
OBL: Visomat, Zum Ottersberg 8-9, 97877 Wertheim am Main, GERMANY.
OEM: UEBE Medical GmbH, Zum Ottersberg 8-9, 97877 Wertheim am Main, GERMANY.
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
Device Manual:
Description:
The Visomat Comfort Form (24035) (v1) 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. This device has been discontinued by the manufacturer but may be available through certain outlets.
Assessment:
The technology used in the Visomat Comfort Form (24035) (v1), 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) | (Previous) | Used as seed device for derivative(s) |
| BP | ESH (Europe) | Self-measurement | Published evidence |
| BP | Stride BP | Self-measurement for adults | Published evidence |
Device Family:
Validation Publications:
Bonso E, Dorigatti F, Saladini F, Palatini P. Validation of the Visomat Comfort form device for home blood pressure measurement according to the International Protocol. Blood Press Monit. 2010 Feb;15(1):63-6. doi: 10.1097/MBP.0b013e32833531de. PMID: 20075716.
ESH-IP:2002 - Pass General population