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))

510(k) 号: K260319
器械名称: 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))
申请人: Zhenjiang Assure Medical Equipment Co., Ltd. CN
产品代码: IOR — Wheelchair, Mechanical
批准日期: 2026-03-31
受理日期: 2026-01-30
决定: Substantially Equivalent
审查途径: Traditional
咨询委员会: Physical Medicine

510(k) Summary（FDA 官方 PDF）： K260319.pdf

FDA 官方记录： K260319

数据来自 openFDA 510(k) 数据集（CC0 公有领域），以 FDA 现行记录为准。510(k) 许可不等于 FDA 认证或批准。