C.T.M. MOBILITY SCOOTER, MODEL H2-686, HS-740, HS-580— 510(k) K000356
Substantially EquivalentWarepalmy Enterprise, LLC (Usa)
FDA 510(k) clearance K000356 for C.T.M. MOBILITY SCOOTER, MODEL H2-686, HS-740, HS-580, Substantially Equivalent on 2000-08-25. Applicant: Warepalmy Enterprise, LLC (Usa).
Clearance details
- Applicant
- Warepalmy Enterprise, LLC (Usa)
- Product code
- Code INI
- Advisory panel
- Physical Medicine
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Phoenix, AZ, US
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.