STORM SERIES, POWER 9000 SERIES AND POWER TIGER WITH GYROSCOPE CONTROL— 510(k) K993413
Substantially EquivalentInvacare Corp.
FDA 510(k) clearance K993413 for STORM SERIES, POWER 9000 SERIES AND POWER TIGER WITH GYROSCOPE CONTROL, Substantially Equivalent on 1999-12-15. Applicant: Invacare Corp.. Device class: 2.
Clearance details
- Applicant
- Invacare Corp.
- 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
- Traditional
- Location
- Elyria, OH, US
Recent devices under product code ITI
view allMore clearances from Invacare Corp.
view allAdverse 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 →
Recalls naming K993413
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K993413.
Data sourced from openFDA. This site is unofficial and independent of the FDA.