C.T.M. MOBILITY SCOOTER, MODEL HS-628, INVACARE ORION— 510(k) K091418

Substantially Equivalent

C.T.M. Homecare Product, Inc.

FDA 510(k) clearance K091418 for C.T.M. MOBILITY SCOOTER, MODEL HS-628, INVACARE ORION, Substantially Equivalent on 2009-07-06. Applicant: C.T.M. Homecare Product, Inc..

Clearance details

Applicant: C.T.M. Homecare Product, Inc.
Product code: Code INI
Advisory panel: Physical Medicine
Date received: 2009-05-13
Decision date: 2009-07-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Eugene, OR, US

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Adverse events under product code INI

product code INI

Injury: 171
Other: 1
Total: 172

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.