KUSCHALL CHAMPION, KUSCHALL COMPACT, KUSCHALL ULTRA-LIGHT— 510(k) K041072
Substantially EquivalentInvacare Corporation
FDA 510(k) clearance K041072 for KUSCHALL CHAMPION, KUSCHALL COMPACT, KUSCHALL ULTRA-LIGHT, Substantially Equivalent on 2004-05-12. Applicant: Invacare Corporation. Device class: 1.
Clearance details
- Applicant
- Invacare Corporation
- Product code
- Code IOR
- Device class
- Class 1
- Regulation
- 21 CFR 890.3850
- Advisory panel
- Physical Medicine
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Elyria, OH, US
Recent devices under product code IOR
view allMore clearances from Invacare Corporation
view all- K203210 — Invacare Platinum 5NXG Oxygen Concentrator
- K202379 — Invacare AVIVA Storm RX Power Chair
- K200890 — Invacare Perfecto2V Oxygen Concentrator
- K192216 — Invacare AVIVA FX Power Wheelchair, Model: IFX-20MP
- K191159 — Concentrator with Single battery pack, carry bag with shoulder strap, back pack shoulder straps, A, POC1 USB Bluetooth Dongle, POC1 Invacare Mobile Medical Application Accessory for use on iOS and Android Devices, Invacare Platinum Mobile Oxygen Concentrator with Connectivity
Adverse events under product code IOR
product code IOR- Death
- 10
- Injury
- 232
- Other
- 2
- Total
- 244
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.