PERMOBIL POWERED WHEELCHAIR 1280— 510(k) K991658
Substantially EquivalentPermobil AB
FDA 510(k) clearance K991658 for PERMOBIL POWERED WHEELCHAIR 1280, Substantially Equivalent on 1999-10-08. Applicant: Permobil AB. Device class: 2.
Clearance details
- Applicant
- Permobil AB
- 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
- Sollentuna, SE
Recent devices under product code ITI
view allMore clearances from Permobil AB
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 K991658
K-number listed on FDA's recall record- Z-3178-2018 — Permobil powered wheelchairs, Model Numbers: (a) M300 PS, (b) C300 PS, (c) C350 PS, (d) C500 PS, (e) C400 PS Product Usage: The devices identified are intended to provide outdoor and indoor mobility to persons limited to a seated position that can operate a powered wheelchair.
- Z-0005-2018 — Electric Wheelchairs: a) C300 CORPUS II b) C350 CORPUS II c) C400 CORPUS II d) C400 CORPUS II LR e) C500 CORPUS II f) C500 CORPUS II LR
- Z-0006-2018 — Electric Wheelchair bases: a) C300 b) C350 c) C400 d) C500
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K991658.
Data sourced from openFDA. This site is unofficial and independent of the FDA.