YJ-K1K2 Wheelchair (YJ-013F)— 510(k) K260145
Substantially EquivalentZhenjiang Assure Medical Equipment Co., Ltd.
FDA 510(k) clearance K260145 for YJ-K1K2 Wheelchair (YJ-013F), Substantially Equivalent on 2026-09-15. Applicant: Zhenjiang Assure Medical Equipment Co., Ltd.. Device class: 1.
Summary
YJ-K1K2 Wheelchair (YJ-013F) comes from Zhenjiang Assure Medical Equipment Co., Ltd. under product code IOR (Wheelchair, Mechanical). Beyond the model number, the record has no detail.
Class I, 21 CFR 890.3850. Physical Medicine is both the classification panel and the review panel, and it came in as a Special 510(k). The decision was Substantially Equivalent.
Zhenjiang Assure filed from Zhenjiang City, China. The decision came 238 calendar days after FDA received it (January 20 to September 15, 2026).
Clearance details
- Applicant
- Zhenjiang Assure Medical Equipment Co., Ltd.
- Product code
- Product code IOR
- Device class
- Class 1
- Regulation
- 21 CFR 890.3850
- Advisory panel
- Physical Medicine
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Zhenjiang City, CN
Recent devices under product code IOR
view allMore clearances from Zhenjiang Assure Medical Equipment Co., Ltd.
view all- K260319 — K5 wheelchair (16 with swing-away footrest 18 with swing-away footrest 20 with swing-away footrest 16 with elevated foot rest(ELR) 18 with elevated foot rest(ELR) 20 with elevated foot rest(ELR))
- K251159 — Power wheelchair
- K232230 — YJ-K1/K2 Wheelchair (YJ-K1F 16 NDE +23 more
- K232198 — Reclining wheelchair (YJ-011S 16D, YJ-011S 16DF, YJ-011S 18D, YJ-011S 18DF, YJ-011S 20D, YJ-011S 20DF)
- K232199 — Bariatric Heavy Duty Wheelchair (YJ-010B 20DS +23 more
Adverse events under product code IOR
product code IOR- Death
- 10
- Injury
- 232
- Other
- 2
- Total
- 244
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.