510(k) clearance
YJ-K1K2 Wheelchair (YJ-013F)
- 510(k) number
- K260145
- Applicant
- Zhenjiang Assure Medical Equipment Co., Ltd.
- Decision date
- Sep 15, 2026
- Date received
- Jan 20, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Product code
- IOR
- Device type
- Wheelchair, Mechanical
- Device class
- Class I
- Regulation
- 21 CFR 890.3850
- Advisory committee
- Physical Medicine
- Statement or summary
- Summary
- Third party
- N
- Location
- Zhenjiang City, CN