FDA.reportPublic FDA data

510(k) K243783

Device
Walking rehabilitation training electric wheelchair (ZW518)
Applicant
Shenzhen Zuowei Technology Co., Ltd.
510(k) number
K243783
Product code
IPL
Decision
Substantially Equivalent (SESE)
Decision date
2025-03-12
Date received
2024-12-09
Regulation
890.3900
Classification name
Wheelchair, Standup
Medical specialty
Physical Medicine
Review panel
Physical Medicine
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
N

Applicant Contact#

Contact
Xingping Long
Address
Floor 2nd, Bldg. 7th, Yi Fenghua Innovation Industrial Pk Xinshi Subdistrict, Dalang St., Longhua District Shenzhen CN

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

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