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510(k) clearance

Electric wheelchair (LW01301A02/LW01301A02L/LW01301A02T)

FDA 510(k) source

510(k) number
K263005
Applicant
Anhui Longway Medical Technology Co., Ltd.
Decision date
Oct 28, 2026
Date received
Aug 28, 2026
Decision
Substantially Equivalent
Clearance type
Traditional
Product code
ITI
Device type
Wheelchair, Powered
Device class
Class II
Regulation
21 CFR 890.3860
Advisory committee
Physical Medicine
Statement or summary
Statement
Third party
N
Location
Mingguang, CN