DeviceClearance

Q6 Edge EM— 510(k) K143383

Substantially Equivalent

Pride Mobility Product Corporation

FDA 510(k) clearance K143383 for Q6 Edge EM, Substantially Equivalent on 2015-07-23. Applicant: Pride Mobility Product Corporation. Device class: 2.

Clearance details

Applicant
Pride Mobility Product Corporation
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
Exeter, PA, US
Download summary PDFView on FDA.gov ↗

Recent devices under product code ITI

view all

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 →

Recalls naming K143383

K-number listed on FDA's recall record

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K143383.

Data sourced from openFDA. This site is unofficial and independent of the FDA.