Greater Goods Balance 0040
Device Name:
Balance
Device Model:
0040
Manufacturer:
OBL: Greater Goods LLC, 1301 S Vandeventer Ave., St. Louis, MO 63110, 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
Availability:
Available Currently
Availability according to Countries or Regions:
United States
Description:
The Greater Goods Balance 0040 is an automatic blood pressure monitor. Medaval has not found evidence proving the accuracy of its blood pressure measurement technology. Blood pressure measurements are taken from the upper arm. It is intended for self-measurement and home use.
Assessment:
While the technology used in the Greater Goods Balance 0040, to measure blood pressure, has been declared as being equivalent to that used in another device, not only has 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, but there is no evidence provided on a validation of the other device.
Recommendations:
| Accuracy Assessment | Recommendation | Basis | |
| BP | Medaval | Not recommended | This device has not been shown to have been clinically validated. |
| BP | AMA VDL (US) | Self-measurement | Manufacturer declaration of equivalence |
Device Family:
Greater Goods Balance 0604L, Greater Goods Balance 0040L, Greater Goods Balance 0664L
Legend: L AHA VDL Implied Equivalence
Legend: L AHA VDL Implied Equivalence
