Empulse M90— 510(k) K242327
Substantially EquivalentConcourse Assistive Technology Pty, Ltd.
FDA 510(k) clearance K242327 for Empulse M90, Substantially Equivalent on 2024-12-10. Applicant: Concourse Assistive Technology Pty, Ltd.. Device class: 2.
Clearance details
- Applicant
- Concourse Assistive Technology Pty, Ltd.
- Product code
- Code ITI
- Device class
- Class 2
- Regulation
- 21 CFR 890.3860
- Advisory panel
- Physical Medicine
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mount Kuring-Gai, AU
Recent devices under product code ITI
view allAdverse events under product code ITI
product code ITI- Death
- 34
- Injury
- 778
- Malfunction
- 1,085
- Other
- 1
- Total
- 1,898
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.