Merlexi Craft Bariatric series of manual wheelchairs— 510(k) K240120
Substantially EquivalentTurbo Wheelchair Co., Inc.
FDA 510(k) clearance K240120 for Merlexi Craft Bariatric series of manual wheelchairs, Substantially Equivalent on 2024-07-05. Applicant: Turbo Wheelchair Co., Inc..
Clearance details
- Applicant
- Turbo Wheelchair Co., Inc.
- Product code
- Code IOR
- Advisory panel
- Physical Medicine
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Jeffersonville, IN, US
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.