510(k) clearances

Power Wheelchair (OS-R-M01I)

Beijing OrionStar Technology Co., Ltd. · Physical Medicine

K260053Substantially EquivalentTraditionalITI
Open FDA's page for this record
Third party flag
N
City
Beijing
Advisory committee description
Physical Medicine
Address 1
Rm. 1201-7, 12th Floor, Bldg. 1, Yard 60
Address 2
Heping W. Rd., Shijingshan District
Statement or summary
Statement
Product code
ITI
Applicant
Beijing OrionStar Technology Co., Ltd.
Decision date
2026-09-08
Decision code
SESE
Country code
CN
Device name
Power Wheelchair (OS-R-M01I)
Advisory committee
PM
Contact
Shengnan Fang
K number
K260053
Date received
2026-01-08
Review advisory committee
PM
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Wheelchair, Powered
Medical specialty description
Physical Medicine
Regulation number
890.3860
Device class
2
Registration number
3038189190, 8043717, 3007608806, 3004142507, 3015992762, 2027797, 3021959198, 3014266593, 1531186, 3010461764, 9616873, 3039359026, 3007309323, 3012538618, 3014522447, 3030822491, 3008841035, 3030410174, 3011749761, 3001185828, 8043457, 1220973, 3007963811, 3014273557, 3004443928, 3043105518, 3011191255, 3027344674, 3045076265, 3002667030, 3038503938, 3031588965, 3013934051, 3022982004, 3043711862, 3044470904, 3014810929, 3042501731, 3008812160, 8030931 +85 more
FEI number
1000334118, 3038189190, 3007608806, 3004142507, 3015992762, 3003767999, 3021959198, 3014266593, 3010461764, 3039359026, 3007309323, 3012538618, 3014522447, 3030822491, 3008841035, 3030410174, 3011749761, 3001185828, 3002889431, 1220973, 3007963811, 3014273557, 3004443928, 3043105518, 3001045529, 3011191255, 3027344674, 3045076265, 3002667030, 3038503938, 3031588965, 3013934051, 3022982004, 3043711862, 3044470904, 3014810929, 3003327839, 3042501731, 3008812160, 3031595780 +85 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.