Reclining wheelchair (YJ-013L)— 510(k) K260144
Substantially EquivalentZhenjiang Assure Medical Equipment Co., Ltd.
FDA 510(k) clearance K260144 for Reclining wheelchair (YJ-013L), Substantially Equivalent on 2026-09-15. Applicant: Zhenjiang Assure Medical Equipment Co., Ltd.. Device class: 1.
Summary
Zhenjiang Assure Medical Equipment Co., Ltd. submitted the Reclining wheelchair (YJ-013L) under product code IOR (Wheelchair, Mechanical). The record gives the model number and no specifications.
Class I, 21 CFR 890.3850. Physical Medicine is both the classification panel and the review panel. It was a Special 510(k), decided Substantially Equivalent.
The company filed from Zhenjiang City, China. FDA received it on January 20, 2026 and decided it on September 15, 2026, 238 calendar days later.
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.