Electric wheelchair (GP100)— 510(k) K262582
Substantially EquivalentSuzhou Green Pine Medical Co., Ltd.
FDA 510(k) clearance K262582 for Electric wheelchair (GP100), Substantially Equivalent on 2026-09-23. Applicant: Suzhou Green Pine Medical Co., Ltd.. Device class: 2.
Summary
This is a powered wheelchair, model GP100, filed under ITI. The device name is generic ("Electric wheelchair"), and the record doesn't give specs.
Class II, 21 CFR 890.3860. The Physical Medicine panel reviewed it as a Traditional 510(k).
Suzhou Green Pine Medical Co., Ltd. filed from Suzhou, China. Review took 58 days (July 27 to September 23, 2026).
Clearance details
- Applicant
- Suzhou Green Pine Medical 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
- Suzhou, 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.