K254206
- 510(k) number
- K254206
- Device name
- Power wheelchair (ZS-EW8026)
- Applicant
- Ningbo Zhishan Medical Technology Co., Ltd. CN
- Product code
- ITI — Wheelchair, Powered
- Decision date
- 2026-03-27
- Date received
- 2025-12-29
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Physical Medicine
PDFDownload 510(k) SummaryArchived here · 0.7 MB · U.S. public domain
Also available from FDA: K254206.pdf
Official FDA record: K254206
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.