M300 & M400— 510(k) K123290
Substantially EquivalentPermobil AB
FDA 510(k) clearance K123290 for M300 & M400, Substantially Equivalent on 2013-04-17. 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
- Traditional
- Location
- Timra, 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 K123290
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 K123290.
Data sourced from openFDA. This site is unofficial and independent of the FDA.