Electric wheelchair (HC819N, HC830N, HC831N)— 510(k) K260229
Substantially EquivalentYongkang Hengyi Vehicle Co., Ltd.
FDA 510(k) clearance K260229 for Electric wheelchair (HC819N, HC830N, HC831N), Substantially Equivalent on 2026-09-08. Applicant: Yongkang Hengyi Vehicle Co., Ltd.. Device class: 2.
Summary
Yongkang Hengyi Vehicle's electric wheelchair is cleared in three models: HC819N, HC830N, and HC831N. It's filed under ITI, powered wheelchairs, and the record doesn't say how the models differ.
Class II, 21 CFR 890.3860. Physical Medicine is both the classification panel and the review panel, and the submission was a Traditional 510(k).
The company filed from Yongkang, China. Review took 225 calendar days (January 26 to September 8, 2026).
Clearance details
- Applicant
- Yongkang Hengyi Vehicle 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 allMore clearances from Yongkang Hengyi Vehicle Co., Ltd.
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.