C.T.M. MOBILITY SCOOTER MODEL # HS-320— 510(k) K012791

Substantially Equivalent

Warepalmy Enterprise, LLC (Usa)

FDA 510(k) clearance K012791 for C.T.M. MOBILITY SCOOTER MODEL # HS-320, Substantially Equivalent on 2001-10-24. Applicant: Warepalmy Enterprise, LLC (Usa).

Clearance details

Applicant: Warepalmy Enterprise, LLC (Usa)
Product code: Code INI
Advisory panel: Physical Medicine
Date received: 2001-08-20
Decision date: 2001-10-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Phoenix, AZ, 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.