AccessGUDID - DEVICE: Momentum Spine (00628774533007)

GUDID

Device Identifier (DI) Information

Brand Name: Momentum Spine
Version or Model: Momentum Spine
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Momentum Health Inc

Primary DI Number: 00628774533007
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 243275304 *Terms of Use

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.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
67120	Posture imaging/analysis software	A 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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LDK	Device, Sensing, Optical Contour

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K232023	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 44783a96-6028-4bc8-ae3e-13258252843c
Public Version Date: July 07, 2025
Public Version Number: 1
DI Record Publish Date: June 29, 2025