INVACARE POWERED WHEELCHAIRS, MODELS M50, M51, M71 & M91— 510(k) K021680
Substantially EquivalentInvacare Corp.
FDA 510(k) clearance K021680 for INVACARE POWERED WHEELCHAIRS, MODELS M50, M51, M71 & M91, Substantially Equivalent on 2002-06-18. 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 K021680
K-number listed on FDA's recall record- Z-2358-2015 — Invacare¿ Pronto¿ Air Personal Transporter (power wheelchair), Invacare Corporation, One Invacare Way, Elyria, Ohio, 44035-4190, (800) 333 -6900.
- Z-2091-2014 — MK5 NX Controller--Wheelchair controller
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K021680.
Data sourced from openFDA. This site is unofficial and independent of the FDA.