JOBSITE ENHANCED MOBILITY CHAIR, MODEL JEM— 510(k) K002876

Substantially Equivalent

Suiter Medical LLC

FDA 510(k) clearance K002876 for JOBSITE ENHANCED MOBILITY CHAIR, MODEL JEM, Substantially Equivalent on 2000-10-11. Applicant: Suiter Medical LLC.

Clearance details

Applicant
Suiter Medical LLC
Product code
Code IOR
Advisory panel
Physical Medicine
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Mc Cook, NE, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code IOR

product code IOR
Death
10
Injury
232
Other
2
Total
244

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.