PROCEDURAL STRECHER WITH INTELLIDRIVE P8000— 510(k) K112502

Substantially Equivalent

Hill-Rom Co.

FDA 510(k) clearance K112502 for PROCEDURAL STRECHER WITH INTELLIDRIVE P8000, Substantially Equivalent on 2011-09-19. Applicant: Hill-Rom Co..

Clearance details

Applicant: Hill-Rom Co.
Product code: Code INK
Advisory panel: Physical Medicine
Date received: 2011-08-30
Decision date: 2011-09-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Batesville, IN, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code INK

product code INK

Malfunction: 708
Other: 1
Total: 709

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.