Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
IOR — Predicate Candidate Screening
463 FDA 510(k) clearances under this product code; the 50 most recent screened below.
46 daysmedian FDA review time
203 days90th percentile
463clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K261571 | Manual Wheelchair (H008, PCK7) | Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. | 2026-08-06 | 86 | 0 |
| K252370 | GEN 4 JOY Wheelchair | Free Wheelchair Mission | 2026-07-24 | 359 | 0 |
| K261076 | Caregiver-assisted wheelchair (MS02);Caregiver-assisted whee | GuangDong Yong Yi Rehabilitation Equipment Technology Co., Ltd. | 2026-06-22 | 82 | 0 |
| K261075 | Manual Wheelchair (MS01);Manual Wheelchair (MA01) | GuangDong Yong Yi Rehabilitation Equipment Technology Co., Ltd. | 2026-06-22 | 82 | 0 |
| K260849 | ICON 35; ICON 45; ICON 60; ICON 30FAF | Rehasense USA, Inc. | 2026-06-11 | 87 | 0 |
| K260642 | Manual Wheelchair (LW01108) | Anhui Longway Medical Technology Co., Ltd. | 2026-06-02 | 95 | 0 |
| K260295 | Helio Kids; Apex P | Motion Composites | 2026-05-28 | 119 | 0 |
| K254141 | Manual Wheelchair (DY01903(2)) | Guangdong Dayang Medical Technology Co., Ltd. | 2026-05-21 | 150 | 0 |
| K260121 | Manual Wheelchair (7101L, 7102LHD) | Foshan Nanhai Hongchen Medical Equipment Co., Ltd. | 2026-04-28 | 103 | 0 |
| K260319 | K5 wheelchair (16” with swing-away footrest 18” with swing-a | Zhenjiang Assure Medical Equipment Co., Ltd. | 2026-03-31 | 60 | 0 |
| K253632 | Manual Wheelchair (W50) | Jiangsu Jumao X-Care Medical Equipment Co., , Ltd. | 2026-01-29 | 71 | 0 |
| K251886 | EmpowerRide NAVIGATOR | Empower Ride, LLC | 2026-01-12 | 206 | 0 |
| K252825 | Manual Wheelchair (W45) | Jiangsu Jumao X-Care Medical Equipment Co., , Ltd. | 2025-12-05 | 91 | 0 |
| K252828 | Manual Wheelchair (W47) | Jiangsu Jumao X-Care Medical Equipment Co., , Ltd. | 2025-12-05 | 91 | 0 |
| K252687 | Manual Wheelchair (HM305-Air1, HM305-Air2) | Suzhou Master Machinery Manufacturing Co.,Ltd | 2025-11-21 | 87 | 0 |
| K250576 | Flexx Junior (FLX-J00, FLX-J50) | Karma Mobility Co, Ltd. | 2025-11-04 | 250 | 0 |
| K252517 | Manual Wheelchair (SYIV100A008) | Ningbo Shenyu Medical Equipment Co.,Ltd | 2025-10-03 | 53 | 0 |
| K241374 | Manual Wheelchair (S002, S004, S005, S006, S007, S008, S009) | Anhui Jbh Medical Apparatus Co., Ltd. | 2025-02-28 | 289 | 0 |
| K243111 | Bowhead ERA Wheelchairs | Bowhead Design Corp. | 2025-01-10 | 102 | 0 |
| K242722 | Manual Wheelchair (MASY23) | Sichuan Ast Medical Equipment Co., Ltd. | 2024-11-22 | 73 | 0 |
| K242560 | Manual Wheelchair (SYIV100-CA9221) | Foshan Shunkangda Medical Tech Co., Ltd. | 2024-10-24 | 57 | 0 |
| K241460 | Manual Wheelchair | Lichtmega Technology Co., Ltd. | 2024-07-11 | 49 | 0 |
| K240120 | Merlexi Craft Bariatric series of manual wheelchairs | Turbo Wheelchair Co., Inc. | 2024-07-05 | 171 | 0 |
| K232230 | YJ-K1/K2 Wheelchair (YJ-K1F 16 NDE; YJ-K1F 16 NDS; YJ-K1F 18 | Zhenjiang Assure Medical Equipment Co., Ltd. | 2023-10-03 | 68 | 0 |
| K232198 | Reclining wheelchair (YJ-011S 16”D, YJ-011S 16”DF, YJ-011S 1 | Zhenjiang Assure Medical Equipment Co., Ltd. | 2023-09-15 | 52 | 0 |
| K232199 | Bariatric Heavy Duty Wheelchair (YJ-010B 20’’DS; YJ-010B 20’ | Zhenjiang Assure Medical Equipment Co., Ltd. | 2023-09-15 | 52 | 0 |
| K200583 | Ki Mobility Focus CR, Ki Mobility Focus CRe, Ki Mobility Foc | Ki Mobility, LLC | 2023-09-05 | 1278 | 0 |
| K223527 | Little Wave Clik, Rogue XP, Little Wave XP, Spark | Ki Mobility, LLC | 2023-08-31 | 281 | 0 |
| K231750 | MA012 Aluminum wheelchair, MS019 steel wheelchair | Sichuan Ast Medical Equipment Co., Ltd. | 2023-08-15 | 61 | 0 |
| K231110 | Manual Wheelchair (A006) | Ningbo Shenyu Medical Equipment Co.,Ltd | 2023-06-16 | 58 | 0 |
| K231320 | Zhenjiang Assure Mechanical Wheelchair,model:K1 | Zhenjiang Assure Medical Equipment Co., Ltd. | 2023-06-05 | 28 | 0 |
| K220698 | Bambino 3, S3 and S3 Swing, U3 and U3 Light, X | Panthera AB | 2023-02-16 | 344 | 0 |
| K221435 | SUPERTILT PLUS (STP) | Power Plus Mobility | 2022-10-28 | 164 | 0 |
| K220671 | Manual Wheelchair | Hebei Ruilangde Medical Equipment Technology Group Co., Ltd. | 2022-07-21 | 136 | 0 |
| K200715 | RoughRider Aurora Manual Wheelchair | Roughrider America, LLC | 2022-06-24 | 828 | 0 |
| K213790 | Aluminum back folding wheelchair SYIV 100-LQXAL2482-407 | Mobility Source Medical Technology Co., Ltd. | 2022-03-14 | 98 | 0 |
| K200466 | Manual Wheelchair (Model W28) | Jiangsu Jumao X-Care Medical Equipment Co., Ltd. | 2021-06-14 | 474 | 0 |
| K201461 | Manual Wheelchair, Model A011 | Ningbo Shenyu Medical Equipment Co.,Ltd | 2021-05-21 | 353 | 0 |
| K200135 | RGK Daily Range Wheelchairs | Rgk Wheelchairs, Ltd. | 2020-09-10 | 233 | 0 |
| K192658 | Manual Wheelchair | Jerry Medical Instrument (Shanghai) Co., Ltd. | 2020-04-01 | 189 | 0 |
| K190550 | IKON 40 Manual Wheelchair | Broda Seating (Broda Lp) | 2019-07-01 | 118 | 0 |
| K190534 | Manual Wheelchair SIVFH2A102 | Jiangsu Horizon Medical Science & Technology Co., Ltd. | 2019-05-29 | 86 | 0 |
| K190699 | Rowheels Revolution 1.0 | Rowheels, Inc. | 2019-05-09 | 52 | 0 |
| K180309 | Manual Wheelchair W54 | Jiangsu Jumao Medical Equipment Co., Ltd. | 2019-05-03 | 455 | 0 |
| K182840 | Element Pediatric Wheelchair | Leggero, LLC | 2019-04-29 | 202 | 0 |
| K180852 | Manual Wheelchair | Jiangyin Newrise Medical Equipment Co., Ltd. | 2019-03-01 | 333 | 0 |
| K181090 | Invacare® Solara® 3G and Solara® 3G Spree Manual Wheelchairs | Invacare Corporation | 2018-11-14 | 203 | 0 |
| K181795 | AST Model MA012 and MS019 Rehab Wheelchair | Sichuan Ast Medical Equipment Co., Ltd. | 2018-09-25 | 82 | 0 |
| K173360 | Athena 190 | Medical Rehab Products, LLC | 2018-05-17 | 203 | 0 |
| K170517 | Merits Model R106/R136 Rehab Wheelchair | Merits Healthcare Industries (Suzhou) Co., Ltd. | 2017-11-16 | 268 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda