# YJ-K1K2 Wheelchair (YJ-013F) (K260145): 510(k) cleared for Zhenjiang Assure Medical Equipment Co., Ltd.

**Predicate Speed & CAPA Advisory Opportunity Score:** 47/100

| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K260145 |
| Device | YJ-K1K2 Wheelchair (YJ-013F) |
| Applicant | Zhenjiang Assure Medical Equipment Co., Ltd. |
| Specialty / panel | Other |
| Product code | IOR |
| Device class | 1 |
| Clearance type | Special |
| Decision | Substantially Equivalent |
| Received | 2026-01-20 |
| Decision date | 2026-09-15 |
| Review time (days) | 238 |
| Third-party review | No |
| Applicant location | Zhenjiang City, CN |

## Why this score
- 238-day review, longer than typical.
- Special 510(k): a modification of an existing device.

Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260145). Last refreshed: 2026-11-04T09:16:12.111Z.
Data from the FDA openFDA API, which may lag official FDA databases. Informational only; not regulatory or legal advice.