ORION II (HEAVY DUTY 350 LBS AND 500 LBS)— 510(k) K101277

Substantially Equivalent

Future Mobility Healthcare, Inc.

FDA 510(k) clearance K101277 for ORION II (HEAVY DUTY 350 LBS AND 500 LBS), Substantially Equivalent on 2010-06-04. Applicant: Future Mobility Healthcare, Inc..

Clearance details

Applicant: Future Mobility Healthcare, Inc.
Product code: Code IOR
Advisory panel: Physical Medicine
Date received: 2010-05-06
Decision date: 2010-06-04
Decision: Substantially Equivalent
Clearance type: Special
Location: Mississauga, Ontario, 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.