Mobility Scooter (BC-MS310)— 510(k) K252817

Substantially Equivalent

Ningbo Baichen Medical Devices Co., Ltd.

FDA 510(k) clearance K252817 for Mobility Scooter (BC-MS310), Substantially Equivalent on 2026-01-02. Applicant: Ningbo Baichen Medical Devices Co., Ltd.. Device class: 2.

Clearance details

Applicant
Ningbo Baichen Medical Devices Co., Ltd.
Product code
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
Ningbo, CN
Download summary PDFView on FDA.gov ↗

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Adverse 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.