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FDA 510(k) Applications Submitted by Zhenjiang Assure Medical Equipment Co., Ltd.
FDA 510(k) Number
Submission Date
Device Name
Applicant
K232198
07/25/2023
Reclining wheelchair (YJ-011S 16öD, YJ-011S 16öDF, YJ-011S 18öD, YJ-011S 18öDF, YJ-011S 20öD, YJ-011S 20öDF)
Zhenjiang Assure Medical Equipment Co., Ltd.
K232199
07/25/2023
Bariatric Heavy Duty Wheelchair (YJ-010B 20ÆÆDS; YJ-010B 20ÆÆDE; YJ-010B 20ÆÆDFS; YJ-010B 20ÆÆDFE;YJ-010B 20ÆÆADS; YJ-010B 20ÆÆADE; YJ-010B 20ÆÆADFS; YJ-010B 20ÆÆADFE; YJ-010B 22ÆÆDS; YJ-010B 22ÆÆDE; YJ-010B 22ÆÆDFS;YJ-010B 22ÆÆDFE; YJ-010B 22ÆÆADS;YJ-010
Zhenjiang Assure Medical Equipment Co., Ltd.
K232230
07/27/2023
YJ-K1/K2 Wheelchair (YJ-K1F 16 NDE; YJ-K1F 16 NDS; YJ-K1F 18 NDE; YJ-K1F 18 NDS; YJ-K1F 20 NDE; YJ-K1F 20 NDS; YJ-K1F 18 NDEE; YJ-K1F 16 VDE; YJ-K1F 16 VDS; YJ-K1F 18 VDE; YJ-K1F 18 VDS; YJ-K1F 20 VDE; YJ-K1F 20 VDS; YJ-K2 16 VDFE; YJ-K2 16 VDFS; YJ-K2 18
Zhenjiang Assure Medical Equipment Co., Ltd.
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