FDA-cleared K252237

EdgeFlow UW20

Edgecare, Inc.

EdgeFlow UW20 is a wearable ultrasound system for noninvasive periodic bladder-volume measurement in adults with BMI no greater than 30.

Modality
Ultrasound
Anatomy
Urinary bladder
Decision
2026-04-17
FDA-cleared K231677

EdgeFlow UH10

Edgecare Inc.

EdgeFlow UH10 is an ultrasound device intended to measure urine volume in the bladder noninvasively in professional healthcare facilities such as hospitals and clinics by...

Modality
Ultrasound
Anatomy
Urinary bladder
Decision
2024-03-06