510(k) clearances

YJ-K1K2 Wheelchair (YJ-013F)

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

K260145Substantially EquivalentSpecialIOR
Open FDA's page for this record
Third party flag
N
City
Zhenjiang City
Advisory committee description
Physical Medicine
Address 1
#297, Chuqiao Rd.
Statement or summary
Summary
Product code
IOR
Zip code
212016
Applicant
Zhenjiang Assure Medical Equipment Co., Ltd.
Decision date
2026-09-15
Decision code
SESE
Country code
CN
Device name
YJ-K1K2 Wheelchair (YJ-013F)
Advisory committee
PM
Contact
Mei Ying
K number
K260145
Date received
2026-01-20
Review advisory committee
PM
Postal code
212016
Decision description
Substantially Equivalent
Clearance type
Special
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.