Q6 Edge EM— 510(k) K143383
Substantially EquivalentPride Mobility Product Corporation
FDA 510(k) clearance K143383 for Q6 Edge EM, Substantially Equivalent on 2015-07-23. Applicant: Pride Mobility Product Corporation.
Clearance details
- Applicant
- Pride Mobility Product Corporation
- Product code
- Code ITI
- Advisory panel
- Physical Medicine
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Exeter, PA, US
Adverse 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.