Momentum Spine

GUDID 00628774533007

The Momentum Spine app is an optical contour sensing mobile application intended to quantify asymmetries, assess body angles and curve progression related to postural asymmetries, including scoliosis. The device is available directly to lay users (Over-the-Counter) and may also be prescribed for use by physicians. The device is intended for use in patients 8 years and older.

Momentum Health Inc

Posture imaging/analysis software
Primary Device ID00628774533007
NIH Device Record Key44783a96-6028-4bc8-ae3e-13258252843c
Commercial Distribution StatusIn Commercial Distribution
Brand NameMomentum Spine
Version Model NumberMomentum Spine
Company DUNS243275304
Company NameMomentum Health Inc
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone514-566-0418
Emailcontact@momentum.health
Phone514-566-0418
Emailcontact@momentum.health
Phone514-566-0418
Emailcontact@momentum.health
Phone514-566-0418
Emailcontact@momentum.health
Phone514-566-0418
Emailcontact@momentum.health
Phone514-566-0418
Emailcontact@momentum.health
Phone514-566-0418
Emailcontact@momentum.health
Phone514-566-0418
Emailcontact@momentum.health
Phone514-566-0418
Emailcontact@momentum.health
Phone514-566-0418
Emailcontact@momentum.health
Phone514-566-0418
Emailcontact@momentum.health
Phone514-566-0418
Emailcontact@momentum.health
Phone514-566-0418
Emailcontact@momentum.health
Phone514-566-0418
Emailcontact@momentum.health
Phone514-566-0418
Emailcontact@momentum.health

Device Identifiers

Device Issuing AgencyDevice ID
GS100628774533007 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LDKDevice, Sensing, Optical Contour

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-07-07
Device Publish Date2025-06-29

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