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FDA-cleared K232023

Momentum Spine

Momentum Health Inc.

Authorized purpose: The Momentum Spine optical-contour-sensing mobile application quantifies asymmetries and assesses body angles and curve progression related to postural asymmetries, including scoliosis. It is available over the counter or by prescription for patients aged 8 years and older.

Modality
Optical Surface Imaging
Anatomy
Torso and spine; postural asymmetry and scoliosis
Decision
2023-10-04