510(k) Report

Devices descending from K201461

12 later devices reach Manual Wheelchair, Model A011 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K261919Multifunctional wheelchair (YJ-059)Zhenjiang Assure Medical Equipment Co., Ltd.20260—
+1K241460Manual WheelchairLichtmega Technology Co., Ltd.20240—
+1K232230YJ-K1/K2 Wheelchair (YJ-K1F 16 NDE; YJ-K1F 16 NDS; YJ-K1F 18 NDE; YJ-K1F 18 NDS; YJ-K1F…Zhenjiang Assure Medical Equipment Co., Ltd.20232—
+1K232199Bariatric Heavy Duty Wheelchair (YJ-010B 20’’DS; YJ-010B 20’’DE; YJ-010B 20’’DFS…Zhenjiang Assure Medical Equipment Co., Ltd.20231—
+1K232198Reclining wheelchair (YJ-011S 16”D, YJ-011S 16”DF, YJ-011S 18”D, YJ-011S 18”DF, YJ-011S…Zhenjiang Assure Medical Equipment Co., Ltd.20233—
+1K231110Manual Wheelchair (A006)Ningbo Shenyu Medical Equipment Co.,Ltd20230—
+2K260144Reclining wheelchair (YJ-013L)Zhenjiang Assure Medical Equipment Co., Ltd.20260—
+2K260141Bariatric Heavy Duty Wheelchair (YJ-010V, YJ-010C)Zhenjiang Assure Medical Equipment Co., Ltd.20260—
+2K260145YJ-K1K2 Wheelchair (YJ-013F)Zhenjiang Assure Medical Equipment Co., Ltd.20260—
+2K261571Manual Wheelchair (H008, PCK7)Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.20260—
+2K260319K5 wheelchair (16” with swing-away footrest 18” with swing-away footrest 20” with…Zhenjiang Assure Medical Equipment Co., Ltd.20260—
+2K241374Manual Wheelchair (S002, S004, S005, S006, S007, S008, S009)Anhui Jbh Medical Apparatus Co., Ltd.20250—