510(k) clearances

Manual Wheelchair (H008, PCK7)

Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. · Physical Medicine

K261571Substantially EquivalentTraditionalIOR
Open FDA's page for this record
Third party flag
N
City
Danyang Jiangsu
Advisory committee description
Physical Medicine
Address 1
Yunyang Industrial Park Danyang City
Address 2
#1 Baisheng Rd. Development Zone
Statement or summary
Summary
Product code
IOR
Zip code
212300
Applicant
Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.
Decision date
2026-08-06
Decision code
SESE
Country code
CN
Device name
Manual Wheelchair (H008, PCK7)
Advisory committee
PM
Contact
Fang (Fawn) Zhang
K number
K261571
Date received
2026-05-12
Review advisory committee
PM
Postal code
212300
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.