Data / Medical devices / Canada / Amico Clinical Solutions
Amico Clinical Solutions: FDA-registered device maker in Richmond Hill Ontario, Canada, 3 510(k) clearances
Amico Clinical Solutions is registered with the FDA (registration 3007682310) in Richmond Hill Ontario, Canada. It lists 3 device types. The FDA files 3 510(k) clearances under its listings, the newest dated October 30, 2013. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3007682310
- FEI number
- 1000214453
- Address
- 122 East Beaver Creek Rd, Richmond Hill Ontario, Canada, L4B 1G6
- Owner or operator
- Amico Clinical Solutions (10031255)
- Roles
- Manufacturer
- First device listed
- February 10, 2010
- Registered through
- 2026
- Brand names listed
- Amico iCE LED Light, Pearl 130 & 160 MC, Pearl 130 & 160 SC, Pendant-Boom, Spectra, Saturn and V-Series, patient lift
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Lift, Patient, Non-Ac-Powered | FSA | 1 | Manufacturer | accessdata.fda.gov |
| Light, Surgical, Ceiling Mounted | FSY | 2 | Manufacturer | accessdata.fda.gov |
| Table, Operating-Room, Ac-Powered | FQO | 1 | 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 30, 2013 | K131893 | AMICO CE SERIES SURGICAL LIGHTS, MIRA LED SERIES MINOR SURGICAL LIGHTS | FSY | Substantially Equivalent | Ajw Technology Consultants, Inc. | accessdata.fda.gov |
| April 1, 2010 | K093010 | MACH LED MC | FSY | Substantially Equivalent | Dr. Mach GmbH & Co. KG | accessdata.fda.gov |
| April 1, 2010 | K093009 | MACH LED SC | FSY | Substantially Equivalent | Dr. Mach GmbH & Co. KG | accessdata.fda.gov |
Compare with other makers
- All makers of Table, Operating-Room, Ac-Powered
- All makers of Light, Surgical, Ceiling Mounted
- All makers of Lift, Patient, Non-Ac-Powered
Updated October 30, 2013. 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.