FDA Product Code
FDA Product Code IOR — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- Physical Medicine
- 21 CFR Citation
- 890.3850
510(k) Clearances — 468 records · page 1 of 5
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K253762 | ErgoSteel (ES0001/696) | Strongback Mobility AG C/O Blueaudit GmbH | 2026-09-22 | Traditional | PDF ↗ |
| K261919 | Multifunctional wheelchair (YJ-059) | Zhenjiang Assure Medical Equipment Co., Ltd. | 2026-09-16 | Traditional | PDF ↗ |
| K260145 | YJ-K1K2 Wheelchair (YJ-013F) | Zhenjiang Assure Medical Equipment Co., Ltd. | 2026-09-15 | Special | PDF ↗ |
| K260141 | Bariatric Heavy Duty Wheelchair (YJ-010V, YJ-010C) | Zhenjiang Assure Medical Equipment Co., Ltd. | 2026-09-15 | Special | PDF ↗ |
| K260144 | Reclining wheelchair (YJ-013L) | Zhenjiang Assure Medical Equipment Co., Ltd. | 2026-09-15 | Special | PDF ↗ |
| K261571 | Manual Wheelchair (H008, PCK7) | Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. | 2026-08-06 | Traditional | PDF ↗ |
| K252370 | GEN 4 JOY Wheelchair | Free Wheelchair Mission | 2026-07-24 | Traditional | PDF ↗ |
| K261075 | Manual Wheelchair (MS01);Manual Wheelchair (MA01) | GuangDong Yong Yi Rehabilitation Equipment Technology Co., Ltd. | 2026-06-22 | Traditional | PDF ↗ |
| K261076 | Caregiver-assisted wheelchair (MS02);Caregiver-assisted wheelchair (MA02) | GuangDong Yong Yi Rehabilitation Equipment Technology Co., Ltd. | 2026-06-22 | Traditional | PDF ↗ |
| K260849 | ICON 35; ICON 45; ICON 60; ICON 30FAF | Rehasense USA, Inc. | 2026-06-11 | Traditional | PDF ↗ |
| K260642 | Manual Wheelchair (LW01108) | Anhui Longway Medical Technology Co., Ltd. | 2026-06-02 | Traditional | PDF ↗ |
| K260295 | Helio Kids; Apex P | Motion Composites | 2026-05-28 | Traditional | PDF ↗ |
| K254141 | Manual Wheelchair (DY01903(2)) | Guangdong Dayang Medical Technology Co., Ltd. | 2026-05-21 | Traditional | PDF ↗ |
| K260121 | Manual Wheelchair (7101L, 7102LHD) | Foshan Nanhai Hongchen Medical Equipment Co., Ltd. | 2026-04-28 | Traditional | PDF ↗ |
| 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)) | Zhenjiang Assure Medical Equipment Co., Ltd. | 2026-03-31 | Traditional | PDF ↗ |
| K253632 | Manual Wheelchair (W50) | Jiangsu Jumao X-Care Medical Equipment Co., , Ltd. | 2026-01-29 | Traditional | PDF ↗ |
| K251886 | EmpowerRide NAVIGATOR | Empower Ride, LLC | 2026-01-12 | Traditional | PDF ↗ |
| K252825 | Manual Wheelchair (W45) | Jiangsu Jumao X-Care Medical Equipment Co., , Ltd. | 2025-12-05 | Traditional | PDF ↗ |
| K252828 | Manual Wheelchair (W47) | Jiangsu Jumao X-Care Medical Equipment Co., , Ltd. | 2025-12-05 | Traditional | PDF ↗ |
| K252687 | Manual Wheelchair (HM305-Air1, HM305-Air2) | Suzhou Master Machinery Manufacturing Co.,Ltd | 2025-11-21 | Traditional | PDF ↗ |
| K250576 | Flexx Junior (FLX-J00, FLX-J50) | Karma Mobility Co, Ltd. | 2025-11-04 | Traditional | PDF ↗ |
| K252517 | Manual Wheelchair (SYIV100A008) | Ningbo Shenyu Medical Equipment Co.,Ltd | 2025-10-03 | Traditional | PDF ↗ |
| K241374 | Manual Wheelchair (S002, S004, S005, S006, S007, S008, S009) | Anhui Jbh Medical Apparatus Co., Ltd. | 2025-02-28 | Traditional | PDF ↗ |
| K243111 | Bowhead ERA Wheelchairs | Bowhead Design Corp. | 2025-01-10 | Traditional | PDF ↗ |
| K242722 | Manual Wheelchair (MASY23) | Sichuan Ast Medical Equipment Co., Ltd. | 2024-11-22 | Traditional | PDF ↗ |
| K242560 | Manual Wheelchair (SYIV100-CA9221) | Foshan Shunkangda Medical Tech Co., Ltd. | 2024-10-24 | Traditional | PDF ↗ |
| K241460 | Manual Wheelchair | Lichtmega Technology Co., Ltd. | 2024-07-11 | Traditional | PDF ↗ |
| K240120 | Merlexi Craft Bariatric series of manual wheelchairs | Turbo Wheelchair Co., Inc. | 2024-07-05 | Traditional | PDF ↗ |
| 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) | Zhenjiang Assure Medical Equipment Co., Ltd. | 2023-10-03 | Traditional | PDF ↗ |
| K232199 | Bariatric Heavy Duty Wheelchair (YJ-010B 20DS; YJ-010B 20DE; YJ-010B 20DFS; YJ-010B 20DFE;YJ-010B 20ADS; YJ-010B 20ADE; YJ-010B 20ADFS; YJ-010B 20ADFE; YJ-010B 22DS; YJ-010B 22DE; YJ-010B 22DFS;YJ-010B 22DFE; YJ-010B 22ADS;YJ-010B 22ADE; YJ-010B 22ADFS; YJ-010B 22ADFE; YJ-010B 24DS; YJ-010B 24DE; YJ-010B 24DFS; YJ-010B 24DFE; YJ-010B 24ADS; YJ-010B 24ADE; YJ-010B 22ADFS; YJ-010B 24ADFE) | Zhenjiang Assure Medical Equipment Co., Ltd. | 2023-09-15 | Traditional | PDF ↗ |
| K232198 | Reclining wheelchair (YJ-011S 16D, YJ-011S 16DF, YJ-011S 18D, YJ-011S 18DF, YJ-011S 20D, YJ-011S 20DF) | Zhenjiang Assure Medical Equipment Co., Ltd. | 2023-09-15 | Traditional | PDF ↗ |
| K200583 | Ki Mobility Focus CR, Ki Mobility Focus CRe, Ki Mobility Focus CR TTL | Ki Mobility, LLC | 2023-09-05 | Traditional | PDF ↗ |
| K223527 | Little Wave Clik, Rogue XP, Little Wave XP, Spark | Ki Mobility, LLC | 2023-08-31 | Traditional | PDF ↗ |
| K231750 | MA012 Aluminum wheelchair, MS019 steel wheelchair | Sichuan Ast Medical Equipment Co., Ltd. | 2023-08-15 | Traditional | PDF ↗ |
| K231110 | Manual Wheelchair (A006) | Ningbo Shenyu Medical Equipment Co.,Ltd | 2023-06-16 | Traditional | PDF ↗ |
| K231320 | Zhenjiang Assure Mechanical Wheelchair,model:K1 | Zhenjiang Assure Medical Equipment Co., Ltd. | 2023-06-05 | Special | PDF ↗ |
| K220698 | Bambino 3, S3 and S3 Swing, U3 and U3 Light, X | Panthera AB | 2023-02-16 | Traditional | PDF ↗ |
| K221435 | SUPERTILT PLUS (STP) | Power Plus Mobility | 2022-10-28 | Traditional | PDF ↗ |
| K220671 | Manual Wheelchair | Hebei Ruilangde Medical Equipment Technology Group Co., Ltd. | 2022-07-21 | Traditional | PDF ↗ |
| K200715 | RoughRider Aurora Manual Wheelchair | Roughrider America, LLC | 2022-06-24 | Traditional | PDF ↗ |
| K213790 | Aluminum back folding wheelchair SYIV 100-LQXAL2482-407 | Mobility Source Medical Technology Co., Ltd. | 2022-03-14 | Traditional | PDF ↗ |
| K200466 | Manual Wheelchair (Model W28) | Jiangsu Jumao X-Care Medical Equipment Co., Ltd. | 2021-06-14 | Traditional | PDF ↗ |
| K201461 | Manual Wheelchair, Model A011 | Ningbo Shenyu Medical Equipment Co.,Ltd | 2021-05-21 | Traditional | PDF ↗ |
| K200135 | RGK Daily Range Wheelchairs | Rgk Wheelchairs, Ltd. | 2020-09-10 | Traditional | PDF ↗ |
| K192658 | Manual Wheelchair | Jerry Medical Instrument (Shanghai) Co., Ltd. | 2020-04-01 | Traditional | PDF ↗ |
| K190550 | IKON 40 Manual Wheelchair | Broda Seating (Broda Lp) | 2019-07-01 | Traditional | PDF ↗ |
| K190534 | Manual Wheelchair SIVFH2A102 | Jiangsu Horizon Medical Science & Technology Co., Ltd. | 2019-05-29 | Traditional | PDF ↗ |
| K190699 | Rowheels Revolution 1.0 | Rowheels, Inc. | 2019-05-09 | Traditional | PDF ↗ |
| K180309 | Manual Wheelchair W54 | Jiangsu Jumao Medical Equipment Co., Ltd. | 2019-05-03 | Traditional | PDF ↗ |
| K182840 | Element Pediatric Wheelchair | Leggero, LLC | 2019-04-29 | Traditional | PDF ↗ |
| K180852 | Manual Wheelchair | Jiangyin Newrise Medical Equipment Co., Ltd. | 2019-03-01 | Traditional | PDF ↗ |
| K181090 | Invacare® Solara® 3G and Solara® 3G Spree Manual Wheelchairs | Invacare Corporation | 2018-11-14 | Traditional | PDF ↗ |
| K181795 | AST Model MA012 and MS019 Rehab Wheelchair | Sichuan Ast Medical Equipment Co., Ltd. | 2018-09-25 | Traditional | PDF ↗ |
| K173360 | Athena 190 | Medical Rehab Products, LLC | 2018-05-17 | Traditional | PDF ↗ |
| K170517 | Merits Model R106/R136 Rehab Wheelchair | Merits Healthcare Industries (Suzhou) Co., Ltd. | 2017-11-16 | Traditional | PDF ↗ |
| K171017 | Convaid Flyer FL12, FL13, FL14, FL15 and FL16; Convaid Flyer transit FL12T, FL13T, FL14T, FL15T and FL16T | Convaid Products, LLC | 2017-10-18 | Traditional | PDF ↗ |
| K163352 | Wheelchair | Kunshan Hi-Fortune Health Products Co., Ltd. | 2017-07-28 | Traditional | PDF ↗ |
| K163432 | Stellar LEAP | Pdg Product Design Group, Inc. | 2017-06-27 | Traditional | PDF ↗ |
| K162328 | Winner Transfer Wheelchair | Winner SG Pte, Ltd. | 2017-05-11 | Traditional | PDF ↗ |
| K162621 | Invacare Tracer SX5 Manual Wheelchair, Invacare Tracer IV Heavy Duty/Extra Wide Manual Wheelchair | Invacare Corporation | 2017-04-17 | Traditional | PDF ↗ |
| K170701 | GEN_2 and GEN_3 Mechanical Wheelchairs | Free Wheelchair Mission | 2017-03-24 | Special | PDF ↗ |
| K162696 | Kuschall Advance Manual Wheelchair | Invacare Corporation | 2016-12-28 | Traditional | PDF ↗ |
| K162686 | Kuschall Champion Manual Wheelchair | Invacare Corporation | 2016-12-28 | Traditional | PDF ↗ |
| K162692 | Kuschall K-Series Attract Manual Wheelchair | Invacare Corporation | 2016-12-28 | Traditional | PDF ↗ |
| K161425 | APEX Manual Wheelchair | Motion Composites | 2016-12-05 | Traditional | PDF ↗ |
| K153328 | SUNCO Mechanical Wheelchair, model SKW-9003 | Danyang Sunco Machinery Co., Ltd. | 2016-07-20 | Traditional | PDF ↗ |
| K151492 | Kudu | R82 A/S | 2016-05-20 | Traditional | PDF ↗ |
| K152021 | Pure Tilt | Proactive Comfort, LLC | 2016-03-31 | Traditional | PDF ↗ |
| K152827 | Weely Manual Wheelchair | Rupiani | 2016-02-19 | Traditional | PDF ↗ |
| K152878 | SUNTEC Mechanical Wheelchair, model ST-WL-1000 | Danyang Suntec Auto Parts Co., Ltd. | 2016-02-03 | Traditional | PDF ↗ |
| K152536 | MyOn HC Manual Wheelchair | Invacare Corporation | 2016-01-05 | Traditional | PDF ↗ |
| K151893 | P.R.O. CG Manual Wheelchair | Freedom Designs, Inc. | 2015-10-22 | Traditional | PDF ↗ |
| K151797 | Nuocande Plastic Manual Wheelchair Model NKD L07 | Ningbo Lecount Medical Technology Co., Ltd. | 2015-08-25 | Traditional | PDF ↗ |
| K143101 | Helio A7 Manual Wheelchair, Move Manual Wheelchair | Motion Composites | 2015-05-01 | Traditional | PDF ↗ |
| K141691 | GEN_3 | Free Wheelchair Mission | 2014-12-17 | Special | PDF ↗ |
| K140023 | ELEVATION | Pdg Product Design Group, Inc. | 2014-10-16 | Traditional | PDF ↗ |
| K140416 | TREKKER, TREKKER TRANSIT | Convaid Products, Inc. | 2014-09-17 | Traditional | PDF ↗ |
| K130017 | VALENTINE STEEL WHEELCHAIR | Valentine Intl. , Ltd. | 2014-05-28 | Traditional | PDF ↗ |
| K130517 | EZ TRANSPORT CHAIR | Harris Medical, LLC | 2014-02-25 | Traditional | PDF ↗ |
| K132257 | MANUAL WHEELCHAIR | Zhejiang Jiafeng Electrical & Mechanial Co., Ltd. | 2014-02-13 | Traditional | PDF ↗ |
| K133855 | BREEZY ELEGANCE | Sunrise Medical (Us), LLC | 2014-01-31 | Traditional | PDF ↗ |
| K130788 | CAPELLA | Future Mobility Healthcare, Inc. | 2013-12-05 | Traditional | PDF ↗ |
| K130848 | SHANGHAI PHOENIX MECHANICAL WHEELCHAIR | Shanghai Phoenix Medical Equipment Co., Ltd. | 2013-11-12 | Traditional | PDF ↗ |
| K131336 | TX WHEELCHAIR CHASSIS | Jcm Seating Solutions, Ltd. | 2013-10-28 | Traditional | PDF ↗ |
| K131529 | SHENGGUANG MANUAL WHEELCHAIR | Pingdingshan Shenxing Healthcare Technology Co., L | 2013-09-24 | Traditional | PDF ↗ |
| K123975 | QUICKIE & ZIPPIE SERIES | Sunrise Medical | 2013-08-16 | Traditional | PDF ↗ |
| K123076 | PROFTHAND MECHANICAL WHEELCHAIR | Harmony Hill International | 2013-08-09 | Abbreviated | PDF ↗ |
| K113164 | DISCOVERY TMAX MANUAL WHEELCHAIR | Otto Bock Healthcare LP | 2013-03-11 | Traditional | PDF ↗ |
| K120391 | MR4500 WHEELCHAIR | Wardray Premise, Ltd. | 2012-12-21 | Traditional | PDF ↗ |
| K120628 | HELIO | Motion Composites | 2012-12-19 | Traditional | PDF ↗ |
| K120501 | CHAMP CHAMP TRANSIT | Convaid Products, Inc. | 2012-09-20 | Traditional | PDF ↗ |
| K120077 | COMED K-SERIES MANUAL WHEELCHAIR | Danyang Comed Healthcare Co., Ltd. | 2012-05-14 | Traditional | PDF ↗ |
| K113713 | GEN_2 MECHANICAL WHEELCHAIR | Free Wheelchair Mission | 2012-05-07 | Traditional | PDF ↗ |
| K112816 | ZHENJIANG ASURE MECHANICAL WHEELCHAIR | Zhenjiang Assure Medical Equipment Co., Ltd. | 2012-04-18 | Traditional | PDF ↗ |
| K120032 | MECHANICAL WHEELCHAIR | Aikin Healthcare Co., Ltd. | 2012-04-13 | Traditional | PDF ↗ |
| K111636 | REHAB TNT, REHAB RAM, REHAB MAC, REHAB KIDSTER, BARIATRIC REHAB TNT AND REHAB RAM | Gunnell, Inc. | 2012-04-03 | Traditional | PDF ↗ |
| K112950 | JIANGSU HEALTHY WAY MECHANICL WHEELCHAIR | Jiangsu Healthy Medical Equipment Co;Ltd | 2012-03-28 | Traditional | PDF ↗ |
| K112948 | JIANGSU HEALTHY WAY MECHANICAL WHEELCHAIR | Jiangsu Healthy Way Medical Equipment Co;Ltd | 2012-03-28 | Traditional | PDF ↗ |
| K120526 | YUYUE K2 WHEELCHAIR, YUYUE K4 WHEELCHAIR | Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. | 2012-03-08 | Traditional | PDF ↗ |
| K111739 | KIDS ROCK 3 CHAIR | Pride Mobility Products Corp. | 2011-08-12 | Special | PDF ↗ |
Product code IOR · Class I · Physical Medicine. Data: openFDA.