SUPERTILT PLUS (STP)— 510(k) K221435

Substantially Equivalent

Power Plus Mobility

FDA 510(k) clearance K221435 for SUPERTILT PLUS (STP), Substantially Equivalent on 2022-10-28. Applicant: Power Plus Mobility.

Clearance details

Applicant: Power Plus Mobility
Product code: Code IOR
Advisory panel: Physical Medicine
Date received: 2022-05-17
Decision date: 2022-10-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Guelph, CA

Download summary PDF View on FDA.gov ↗

Adverse events under product code IOR

product code IOR

Death: 10
Injury: 232
Other: 2
Total: 244

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.