Data / Medical devices / Australia / Concourse Assistive Technology Pty Ltd
Concourse Assistive Technology Pty Ltd: FDA-registered device maker in Wetherill Park New South Wales, Australia, 1 510(k) clearance
Concourse Assistive Technology Pty Ltd is registered with the FDA (registration 3038189190) in Wetherill Park New South Wales, Australia. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated December 10, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3038189190
- Address
- 11 Daniel Street, Wetherill Park New South Wales, Australia, 2164
- Owner or operator
- Concourse Assistive Technology PTY LTD (10092945)
- Roles
- Manufacturer
- First device listed
- March 9, 2025
- Registered through
- 2026
- Brand names listed
- Sunrise medical (US)
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| 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 |
|---|---|---|---|---|---|---|
| December 10, 2024 | K242327 | Empulse M90 | ITI | Substantially Equivalent | Concourse Assistive Technology Pty, Ltd. | accessdata.fda.gov |
Compare with other makers
Updated December 10, 2024. 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.