DeviceClearance

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.. Device class: 2.

Clearance details

Applicant
C.T.M. Homecare Product, Inc.
Product code
Code INI
Device class
Class 2
Regulation
21 CFR 890.3800
Advisory panel
Physical Medicine
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Eugene, OR, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code INI

product code INI
Injury
171
Other
1
Total
172

Source: openFDA MAUDE database, through . 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.