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