Data / Medical devices / Canada / Momentum Health Inc.
Momentum Health Inc.: FDA-registered device maker in Montreal Quebec, Canada, 1 510(k) clearance
Momentum Health Inc. is registered with the FDA (registration 3029900922) in Montreal Quebec, Canada. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated October 4, 2023. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3029900922
- Address
- 2727 Rue St-Patrick Apt. 109, Montreal Quebec, Canada, H3K 0A8
- Owner or operator
- Momentum Health Inc. (10086924)
- Roles
- Exporter to the US, Manufacturer, Specification developer
- First device listed
- October 11, 2023
- Registered through
- 2026
- Brand names listed
- Momentum Brace Monitor, Momentum Spine
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Device, Sensing, Optical Contour | LDK | U | Manufacturer | accessdata.fda.gov |
| Monitor, Orthotic/Prosthetic | NHF | 1 | Exporter to the US, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| October 4, 2023 | K232023 | Momentum Spine | LDK | Substantially Equivalent | Momentum Health, Inc. | accessdata.fda.gov |
Compare with other makers
Updated October 4, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.