Bariatric Power Positioning System (BPPS)— 510(k) K182995

Substantially Equivalent

Motion Concepts

FDA 510(k) clearance K182995 for Bariatric Power Positioning System (BPPS), Substantially Equivalent on 2019-03-08. Applicant: Motion Concepts.

Clearance details

Applicant: Motion Concepts
Product code: Code ITI
Advisory panel: Physical Medicine
Date received: 2018-10-30
Decision date: 2019-03-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Concord, CA

Download summary PDF View on FDA.gov ↗

Adverse events under product code ITI

product code ITI

Death: 34
Injury: 778
Malfunction: 1,085
Other: 1
Total: 1,898

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.