K232198

Reclining wheelchair (YJ-011S 16D, YJ-011S 16DF, YJ-011S 18D, YJ-011S 18DF, YJ-011S 20D, YJ-011S 20DF)

510(k) number: K232198
Device name: Reclining wheelchair (YJ-011S 16D, YJ-011S 16DF, YJ-011S 18D, YJ-011S 18DF, YJ-011S 20D, YJ-011S 20DF)
Applicant: Zhenjiang Assure Medical Equipment Co., Ltd. CN
Product code: IOR — Wheelchair, Mechanical
Decision date: 2023-09-15
Date received: 2023-07-25
Decision: Substantially Equivalent
Clearance type: Traditional
Advisory committee: Physical Medicine

Also available from FDA: K232198.pdf

Official FDA record: K232198

Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.