Power Wheelchair (DC12)— 510(k) K261079
Substantially EquivalentAnhui JBH Medical Apparatus Co., Ltd.
FDA 510(k) clearance K261079 for Power Wheelchair (DC12), Substantially Equivalent on 2026-10-06. Applicant: Anhui JBH Medical Apparatus Co., Ltd.. Device class: 2.
Summary
Anhui JBH Medical Apparatus's Power Wheelchair, model DC12, is filed under ITI, powered wheelchairs. The record doesn't give specifications.
Class II, 21 CFR 890.3860. The Physical Medicine panel reviewed it as a Traditional 510(k).
The company filed from Chuzhou, China. Review took 188 days (April 1 to October 6, 2026). A second Anhui JBH power wheelchair, model D60 (K261200), was decided the same day.
Clearance details
- Applicant
- Anhui JBH Medical Apparatus 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
- Chuzhou, CN
Recent devices under product code ITI
view allMore clearances from Anhui JBH Medical Apparatus 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.