510(k) Report

Devices descending from K162621

22 later devices reach Invacare Tracer SX5 Manual Wheelchair, Invacare Tracer IV Heavy Duty/Extra… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K181795AST Model MA012 and MS019 Rehab WheelchairSichuan Ast Medical Equipment Co., Ltd.201821—
+2K253632Manual Wheelchair (W50)Jiangsu Jumao X-Care Medical Equipment Co.,, Ltd.20260—
+2K252825Manual Wheelchair (W45)Jiangsu Jumao X-Care Medical Equipment Co.,, Ltd.20250—
+2K231750MA012 Aluminum wheelchair, MS019 steel wheelchairSichuan Ast Medical Equipment Co., Ltd.20233—
+2K213790Aluminum back folding wheelchair SYIV 100-LQXAL2482-407Mobility Source Medical Technology Co., Ltd.20220—
+2K201461Manual Wheelchair, Model A011Ningbo Shenyu Medical Equipment Co.,Ltd202112—
+2K190534Manual Wheelchair SIVFH2A102Jiangsu Horizon Medical Science & Technology Co., Ltd.20190—
+3K261919Multifunctional wheelchair (YJ-059)Zhenjiang Assure Medical Equipment Co., Ltd.20260—
+3K261076Caregiver-assisted wheelchair (MS02);Caregiver-assisted wheelchair (MA02)GuangDong Yong Yi Rehabilitation Equipment Technology Co., Ltd.20260—
+3K261075Manual Wheelchair (MS01);Manual Wheelchair (MA01)GuangDong Yong Yi Rehabilitation Equipment Technology Co., Ltd.20260—
+3K242722Manual Wheelchair (MASY23)Sichuan Ast Medical Equipment Co., Ltd.20240—
+3K241460Manual WheelchairLichtmega Technology Co., Ltd.20240—
+3K232230YJ-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—
+3K232199Bariatric Heavy Duty Wheelchair (YJ-010B 20’’DS; YJ-010B 20’’DE; YJ-010B 20’’DFS…Zhenjiang Assure Medical Equipment Co., Ltd.20231—
+3K232198Reclining 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—
+3K231110Manual Wheelchair (A006)Ningbo Shenyu Medical Equipment Co.,Ltd20230—
+4K260144Reclining wheelchair (YJ-013L)Zhenjiang Assure Medical Equipment Co., Ltd.20260—
+4K260141Bariatric Heavy Duty Wheelchair (YJ-010V, YJ-010C)Zhenjiang Assure Medical Equipment Co., Ltd.20260—
+4K260145YJ-K1K2 Wheelchair (YJ-013F)Zhenjiang Assure Medical Equipment Co., Ltd.20260—
+4K261571Manual Wheelchair (H008, PCK7)Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.20260—
+4K260319K5 wheelchair (16” with swing-away footrest 18” with swing-away footrest 20” with…Zhenjiang Assure Medical Equipment Co., Ltd.20260—
+4K241374Manual Wheelchair (S002, S004, S005, S006, S007, S008, S009)Anhui Jbh Medical Apparatus Co., Ltd.20250—