Momentum Spine

Primary DI
00628774533007
Brand
Momentum Spine
Company
Momentum Health Inc
Model
Momentum Spine
Device description
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.
Published
2025-06-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
LDKDevice, Sensing, Optical Contour

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LDKDevice, Sensing, Optical ContourUnknownU

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K232023000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K232023000Momentum SpineMomentum Health, Inc.2023-10-04LDK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00628774533007PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00628774533007006287745330076287745330070628774533007

GMDN Terms#

Term, Definition table
TermDefinition
Posture imaging/analysis softwareA software program intended to be installed on a non-medical smart device with an integrated camera to allow a layperson to: 1) analyse posture based on captured body images for the calculation of body angles and possible misalignments (e.g., Cobb angle); and 2) store image data for tracking changes over time (e.g., misalignment progression). It typically utilizes artificial intelligence (AI) techniques to provide postural data from the images. It does not require clinical consultation; it may additionally be used by a healthcare professional.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
514-566-0418contact@momentum.health

Regulatory Flags#

DUNS number
243275304
Device count
1
Lot or batch
true