K242989
- 510(k) number
- K242989
- Device name
- Electric Wheelchair (MODEL H)
- Applicant
- Nanjing E-Take Medical Apparatus Co., Ltd. CN
- Product code
- ITI — Wheelchair, Powered
- Decision date
- 2024-12-31
- Date received
- 2024-09-26
- 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: K242989
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.