ELECTRIC POWERED LIFT WHEELCHAIR, MODEL VISION (P13)— 510(k) K063320
Substantially EquivalentImc-Heart Way LLC
FDA 510(k) clearance K063320 for ELECTRIC POWERED LIFT WHEELCHAIR, MODEL VISION (P13), Substantially Equivalent on 2007-02-27. Applicant: Imc-Heart Way LLC. Device class: 2.
Clearance details
- Applicant
- Imc-Heart Way LLC
- Product code
- Code ITI
- Device class
- Class 2
- Regulation
- 21 CFR 890.3860
- Advisory panel
- Physical Medicine
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Location
- Fort Myers, FL, US
Recent devices under product code ITI
view allMore clearances from Imc-Heart Way LLC
view all- K063328 — IMC HEARTWAY, LLC ELECTRIC POWERED WHEELCHAIR, MODEL ALLURE (HP6)
- K063307 — ELECTRIC POWERED WHEELCHAIR, MODEL - RUMBA SR (4R)
- K063203 — ELECTRIC WHEELCHAIR, MODEL RUMBA S (HP4)
- K063475 — IMC-HEARTWAY, LLC ELECTRIC WHEELCHAIR, MODEL TIARA (P4AS)
- K063474 — ELECTRIC POWERED WHEELCHAIR MODEL-MINI (P14)
Adverse events under product code ITI
product code ITI- Death
- 34
- Injury
- 778
- Malfunction
- 1,085
- Other
- 1
- Total
- 1,898
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.