PMA
P020033: INDEPENDENCE (TM) IBOT 3000/4000 MOBILITY SYSTEM
FDA PMA · Wheelchair, stair climbing · Independence Technology, LLC
Key facts
| PMA number | P020033 |
|---|---|
| Trade name | INDEPENDENCE (TM) IBOT 3000/4000 MOBILITY SYSTEM |
| Generic name | Wheelchair, stair climbing |
| Applicant | Independence Technology, LLC |
| Owner/operator | ETHICON INC. |
| Product code | IMK |
| Approval date | Aug 13, 2003 |
| Docket number | 03M-0375 |
| Establishment registration | 2210968 |
| FEI number | 2210968 |
At a glance
- 1–9 Supplements
- Mar 15, 2005 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- None UDI device identifiers (GUDID)
- None MAUDE adverse event reports
- None Recall events
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA approvals
Premarket approval (PMA) is the FDA's most stringent review pathway, required for most Class III devices that support or sustain life or present a potentially unreasonable risk.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: