510(k) clearances

Multifunctional wheelchair (YJ-059)

Zhenjiang Assure Medical Equipment Co., Ltd. · Physical Medicine

K261919Substantially EquivalentTraditionalIOR
Open FDA's page for this record
Third party flag
N
City
Zhenjiang
Advisory committee description
Physical Medicine
Address 1
#799, Chuqiao Rd.
Statement or summary
Summary
Product code
IOR
Applicant
Zhenjiang Assure Medical Equipment Co., Ltd.
Decision date
2026-09-16
Decision code
SESE
Country code
CN
Device name
Multifunctional wheelchair (YJ-059)
Advisory committee
PM
Contact
Christine Dong
K number
K261919
Date received
2026-06-09
Review advisory committee
PM
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Wheelchair, Mechanical
Medical specialty description
Physical Medicine
Regulation number
890.3850
Device class
1
Registration number
1417592, 3007608806, 3003162820, 1531186, 2437956, 3010461764, 3039359026, 3032618, 9616091, 3007309323, 3007160937, 3009235818, 3009683397, 3030410174, 3011134213, 3009425497, 1058397, 9681827, 3013538349, 3014273557, 3007912863, 3011191255, 3015967131, 3009302777, 3007289408, 3038189860, 3005720080, 3007499787, 1000252066, 3044470904, 3014810929, 3032597250, 3015220328, 3008058406, 3009407891, 3014293077, 3009327812, 3015772781, 3010273872, 3007518294 +91 more
FEI number
1417592, 3002653226, 1000253203, 3007608806, 3003162820, 3010461764, 3039359026, 3007309323, 3007074101, 3007160937, 3009235818, 3009683397, 3030410174, 3011134213, 3009425497, 3002889431, 1000137528, 3013538349, 3004839326, 3014273557, 3007912863, 3011191255, 3015967131, 3009302777, 3007289408, 3038189860, 3005720080, 3007499787, 1000252066, 3044470904, 3014810929, 3003327839, 3032597250, 3015220328, 3008058406, 3009407891, 3000210114, 3014293077, 3009327812, 3015772781 +91 more
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.