Data / Medical devices / Canada / Arjo Canada Inc.
Arjo Canada Inc.: FDA-registered device maker in Mississauga Ontario, Canada, 1 510(k) clearance
Arjo Canada Inc. is registered with the FDA (registration 3010010434) in Mississauga Ontario, Canada. It lists 4 device types. The FDA files 1 510(k) clearance under its listings, the newest dated May 1, 2000. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3010010434
- Address
- 550 Matheson Blvd. East Unit 7, Mississauga Ontario, Canada, L4Z 4G3
- Owner or operator
- ArjoHuntleigh AB (10036598)
- Roles
- Exporter to the US
- First device listed
- May 17, 2011
- Registered through
- 2026
- Brand names listed
- Arjo Disposable Slide sheets; Arjo Disposable Slide Tube, CITADEL PATIENT CARE SYSTEM (BED FRAME AND MATTRESS), HARMONIE (FOREIGN EXPORTER), SARA PLUS (FOREIGN EXPORTER ONLY), SYSTEM 2000 (FOREIGN EXPORTER), Various Arjo slings
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Aid, Transfer | IKX | 1 | Exporter to the US | accessdata.fda.gov |
| Bath, Hydro-Massage | ILJ | 2 | Exporter to the US | accessdata.fda.gov |
| Bed, Flotation Therapy, Powered | IOQ | 2 | Exporter to the US | accessdata.fda.gov |
| Lift, Patient, Non-Ac-Powered | FSA | 1 | Exporter to the US | 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 |
|---|---|---|---|---|---|---|
| May 1, 2000 | K001079 | RECUMBENT BATHING SYSTEMS, RHAPSODY AND PRIMO | ILJ | Substantially Equivalent | Arjo, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Aid, Transfer
- All makers of Lift, Patient, Non-Ac-Powered
- All makers of Bath, Hydro-Massage
- All makers of Bed, Flotation Therapy, Powered
Updated May 1, 2000. 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.