Power wheelchair (ZS-EW8026)— 510(k) K254206
Substantially EquivalentNingbo Zhishan Medical Technology Co., Ltd.
FDA 510(k) clearance K254206 for Power wheelchair (ZS-EW8026), Substantially Equivalent on 2026-03-27. Applicant: Ningbo Zhishan Medical Technology Co., Ltd.. Device class: 2.
Summary
Ningbo Zhishan Medical Technology's Power wheelchair (ZS-EW8026) is filed under ITI, powered wheelchairs. The name is generic apart from the ZS-EW8026 designation.
Class II, 21 CFR 890.3860. Physical Medicine is both the classification panel and the review panel, and it came in as a Traditional 510(k).
Ningbo Zhishan Medical Technology filed from Ningbo, China. Review took 88 calendar days (December 29, 2025 to March 27, 2026).
Clearance details
- Applicant
- Ningbo Zhishan Medical Technology Co., Ltd.
- Product code
- Product 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
- Ningbo, CN
Recent devices under product code ITI
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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.