FDA UDI
In Commercial Distribution
🇺🇸 United States
Momentum Spine
DI: 00628774533007
·
Model: Momentum Spine
·
Momentum Health Inc
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Momentum Spine
- Primary DI
- 00628774533007
- Version / Model
- Momentum Spine
- Company Name
- Momentum Health Inc
- Labeler DUNS
- 243275304
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-06-29
- Public Version
- 1
- Public Version Date
- 2025-07-07
- Public Version Status
- New
- Public Device Record Key
- 44783a96-6028-4bc8-ae3e-13258252843c
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
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LDK | Device, Sensing, Optical Contour | Unknown | U |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00628774533007 | GS1 |
Customer Contacts
- Phone
- 514-566-0418
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K232023 | 000 |