K242327
- 510(k) number
- K242327
- Device name
- Empulse M90
- Applicant
- Concourse Assistive Technology Pty, Ltd. AU
- Product code
- ITI — Wheelchair, Powered
- Decision date
- 2024-12-10
- Date received
- 2024-08-06
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Physical Medicine
510(k) Summary (official FDA PDF): K242327.pdf
Official FDA record: K242327
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.