Electric Wheelchair (CN501)— 510(k) K262652
Substantially EquivalentZhejiang Shimo Technology Co., Ltd.
FDA 510(k) clearance K262652 for Electric Wheelchair (CN501), Substantially Equivalent on 2026-10-13. Applicant: Zhejiang Shimo Technology Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Zhejiang Shimo 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
- Yongkang, CN
Recent devices under product code ITI
view all- K263005 — Electric wheelchair (LW01301A02/LW01301A02L/LW01301A02T)
- K261155 — Power Wheelchair (DC07A, DC07S, DC08A, DC08S, DC09, DC09A, DC09S, DC09M, DC10A, DC10S)
- K261156 — Power Wheelchair (DC07, DC07M, DC08M, DC09F, DC10M)
- K261169 — Power Wheelchair (D39)
- K263257 — Electrically Powered Wheelchair (YC-01)
Adverse 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.