Data / Medical devices / Canada / Myndtec Inc
Myndtec Inc: FDA-registered device maker in Mississauga Ontario, Canada, 2 510(k) clearances
Myndtec Inc is registered with the FDA (registration 3013927823) in Mississauga Ontario, Canada. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated March 3, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3013927823
- Address
- 7111 Syntex Drive, Suite 301, Mississauga Ontario, Canada, L5N 8C3
- Owner or operator
- MyndTec Inc (10055688)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- September 14, 2017
- Registered through
- 2026
- Brand names listed
- MyndMove, MyndMove 2
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Stimulator, Muscle, Powered | IPF | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Stimulator, Neuromuscular, External Functional | GZI | 2 | Complaint file establishment, Manufacturer | 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 |
|---|---|---|---|---|---|---|
| March 3, 2022 | K212149 | MyndMove 2.0 | GZI | Substantially Equivalent | Myndtec, Inc. | accessdata.fda.gov |
| August 30, 2017 | K170564 | MyndMove System, MyndMove Functional Electrical Stimulator | GZI | Substantially Equivalent | Myndtec, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Stimulator, Neuromuscular, External Functional
- All makers of Stimulator, Muscle, Powered
Updated March 3, 2022. 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.