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510(k) K243783

Walking rehabilitation training electric wheelchair (ZW518) by Shenzhen Zuowei Technology Co., Ltd. — Product Code IPL

K243783 is an FDA 510(k) premarket notification submitted by Shenzhen Zuowei Technology Co., Ltd. for the device "Walking rehabilitation training electric wheelchair (ZW518)". The FDA issued a decision of Substantially Equivalent on March 12, 2025. The device falls under product code IPL (Wheelchair, Standup), a Class II device regulated under 21 CFR 890.3900.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 12, 2025
Date Received
December 9, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Wheelchair, Standup
Device Class
Class II
Regulation Number
890.3900
Review Panel
PM
Submission Type

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FDA data resources