Data / Medical devices / Canada / Amylior, Inc.
Amylior, Inc.: FDA-registered device maker in Vaudreuil-Dorion Quebec, Canada, 3 510(k) clearances
Amylior, Inc. is registered with the FDA (registration 9615410) in Vaudreuil-Dorion Quebec, Canada. It lists 5 device types. The FDA files 3 510(k) clearances under its listings, the newest dated October 9, 2009. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 9615410
- FEI number
- 3003767999
- Address
- 3190 F.X. Tessier, Vaudreuil-Dorion Quebec, Canada, J7V 5V5
- Owner or operator
- AMYLIOR, INC. (9036363)
- Roles
- Complaint file establishment, Exporter to the US, Foreign private label distributor, Manufacturer, Specification developer
- First device listed
- January 28, 2008
- Registered through
- 2026
- Brand names listed
- Alltrack, Amypower, Amyseat, Amyseat II, Amyseat II tilt/recline seating, Amyseat tilt/recline seating, Amysystems, CGair and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessories, Wheelchair | KNO | 1 | Manufacturer | accessdata.fda.gov |
| Cushion, Flotation | KIC | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Cushion, Wheelchair | IMP | 1 | Complaint file establishment, Foreign private label distributor, Specification developer | accessdata.fda.gov |
| Walker, Mechanical | ITJ | 1 | Complaint file establishment, Exporter to the US, Specification developer | accessdata.fda.gov |
| Wheelchair, Powered | ITI | 2 | 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 |
|---|---|---|---|---|---|---|
| October 9, 2009 | K092225 | AMYPOWER ALL TRACK SERIES POWER WHEELCHAIR | ITI | Substantially Equivalent | Amylior, Inc. | accessdata.fda.gov |
| May 11, 2001 | K011006 | AMYSEAT TILT/RECLINE SEATING | ITI | Substantially Equivalent | Amysystems | accessdata.fda.gov |
| January 13, 2000 | K994072 | AMYSYSTEMS PTS50CG 50 DEGREE WEIGHT SHIFT POWER TILT SYSTEM | ITI | Substantially Equivalent | Amylior, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Cushion, Wheelchair
- All makers of Wheelchair, Powered
- All makers of Walker, Mechanical
- All makers of Cushion, Flotation
- All makers of Accessories, Wheelchair
Updated October 9, 2009. 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.