K240120
- 510(k) number
- K240120
- Device name
- Merlexi Craft Bariatric series of manual wheelchairs
- Applicant
- Turbo Wheelchair Co., Inc. IN · US
- Product code
- IOR — Wheelchair, Mechanical
- Decision date
- 2024-07-05
- Date received
- 2024-01-16
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Physical Medicine
This submission filed a 510(k) Statement rather than a Summary; no public summary is available from FDA.
Official FDA record: K240120
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.