Power wheelchair— 510(k) K251159
Substantially EquivalentZhenjiang Assure Medical Equipment Co., Ltd.
FDA 510(k) clearance K251159 for Power wheelchair, Substantially Equivalent on 2025-12-22. Applicant: Zhenjiang Assure Medical Equipment Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Zhenjiang Assure Medical Equipment 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
- Zhenjiang, CN
Recent devices under product code ITI
view allMore clearances from Zhenjiang Assure Medical Equipment Co., Ltd.
view all- K261919 — Multifunctional wheelchair (YJ-059)
- K260141 — Bariatric Heavy Duty Wheelchair (YJ-010V, YJ-010C)
- K260144 — Reclining wheelchair (YJ-013L)
- K260145 — YJ-K1K2 Wheelchair (YJ-013F)
- 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))
Adverse 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.