Mobility Scooter (R200)— 510(k) K261163
Substantially EquivalentYongkang Ruihe Metal Product Co., Ltd.
FDA 510(k) clearance K261163 for Mobility Scooter (R200), Substantially Equivalent on 2026-07-07. Applicant: Yongkang Ruihe Metal Product Co., Ltd.. Device class: 2.
Summary
Yongkang Ruihe Metal Product's Mobility Scooter (R200) is filed under INI, motorized 3-wheeled vehicles. The record gives the model as R200 but no specs.
Class II, 21 CFR 890.3800. Physical Medicine is both the classification panel and the review panel. It was a Traditional 510(k).
Yongkang Ruihe filed from Yongkang, China. The decision came 89 calendar days after receipt (April 9 to July 7, 2026).
Clearance details
- Applicant
- Yongkang Ruihe Metal Product Co., Ltd.
- Product code
- Product code INI
- Device class
- Class 2
- Regulation
- 21 CFR 890.3800
- Advisory panel
- Physical Medicine
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Yongkang, CN
Recent devices under product code INI
view allMore clearances from Yongkang Ruihe Metal Product Co., Ltd.
view allAdverse events under product code INI
product code INI- Injury
- 171
- Other
- 1
- Total
- 172
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.