PMA
P900038: PARASTEP-I
FDA PMA · Stimulator, functional walking neuromuscular, non-invasive · Sigmedics, Inc.
Key facts
| PMA number | P900038 |
|---|---|
| Trade name | PARASTEP-I |
| Generic name | Stimulator, functional walking neuromuscular, non-invasive |
| Applicant | Sigmedics, Inc. |
| Product code | MKD |
| Approval date | Apr 20, 1994 |
| Docket number | 94M-0180 |
| Notice date | Jun 14, 1994 |
| FEI number | 1421416 |
At a glance
- None Supplements
- Apr 20, 1994 Latest supplement decision
- No Withdrawn
- No 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: