510(k) Report

Devices descending from K101277

4 later devices reach Orion II (Heavy Duty 350 LBS and 500 LBS) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K170517Merits Model R106/R136 Rehab WheelchairMerits Healthcare Industries (Suzhou) Co., Ltd.20173—
+2K252828Manual Wheelchair (W47)Jiangsu Jumao X-Care Medical Equipment Co.,, Ltd.20250—
+2K200466Manual Wheelchair (Model W28)Jiangsu Jumao X-Care Medical Equipment Co., Ltd.20210—
+2K180309Manual Wheelchair W54Jiangsu Jumao Medical Equipment Co., Ltd.20190—