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Zhenjiang Assure Medical Equipment Co., Ltd.

Dispositifs autorisés FDA 510(k) et PMA — 10 produits

Nombre total de dispositifs10
Catégories0
Dernière décision de la FDA
TypeNuméroNom du dispositifCodeDateActions
510(k) K261919 Multifunctional wheelchair (YJ-059)IOR2026-09-16 Voir
510(k) K260144 Reclining wheelchair (YJ-013L)IOR2026-09-15 Voir
510(k) K260145 YJ-K1K2 Wheelchair (YJ-013F)IOR2026-09-15 Voir
510(k) K260141 Bariatric Heavy Duty Wheelchair (YJ-010V, YJ-010C)IOR2026-09-15 Voir
510(k) K260319 K5 wheelchair (16” with swing-away footrest 18” with swing-away footrest 20” with swing-away footrest 16” with elevated foot rest(ELR) 18” with elevated foot rest(ELR) 20” with elevated foot rest(ELR))IOR2026-03-31 Voir
510(k) K251159 Power wheelchairITI2025-12-22 Voir
510(k) K232230 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 VDFE; YJ-K2 18 VDFS; YJ-K2 20 VDFE; YJ-K2 20 VDFS; YJ-K1G 18 NFFE; YJ-K1G 18 NFFS; YJ-K2TC 16 NAFE; YJ-K2TC 18 NAFE; YJ-K2TC 20 NAFE)IOR2023-10-03 Voir
510(k) K232198 Reclining wheelchair (YJ-011S 16”D, YJ-011S 16”DF, YJ-011S 18”D, YJ-011S 18”DF, YJ-011S 20”D, YJ-011S 20”DF)IOR2023-09-15 Voir
510(k) K232199 Bariatric Heavy Duty Wheelchair (YJ-010B 20’’DS; YJ-010B 20’’DE; YJ-010B 20’’DFS; YJ-010B 20’’DFE;YJ-010B 20’’ADS; YJ-010B 20’’ADE; YJ-010B 20’’ADFS; YJ-010B 20’’ADFE; YJ-010B 22’’DS; YJ-010B 22’’DE; YJ-010B 22’’DFS;YJ-010B 22’’DFE; YJ-010B 22’’ADS;YJ-010B 22’’ADE; YJ-010B 22’’ADFS; YJ-010B 22’’ADFE; YJ-010B 24’’DS; YJ-010B 24’’DE; YJ-010B 24’’DFS; YJ-010B 24’’DFE; YJ-010B 24’’ADS; YJ-010B 24’’ADE; YJ-010B 22’’ADFS; YJ-010B 24’’ADFE)IOR2023-09-15 Voir
510(k) K231320 Zhenjiang Assure Mechanical Wheelchair,model:K1IOR2023-06-05 Voir
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