ClearanceBrief
Panels › Physical Medicine › Product code IOR · Class 1

Wheelchair, Mechanical

Regulation 890.3850

20510(k)s in 12 months (468 all time)
0recalls in 12 months (40 all time)
31recalls that name a 510(k)
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Top companies in IOR

Company510(k)sRecalls
Invacare Corp.327
Colours 'N Motion120
Freedom Designs, Inc.101
Sunrise Medical91
Zhenjiang Assure Medical Equipment Co., Ltd.100
Everest & Jennings, Inc.90
Pdg Product Design Group, Inc.81
Sunrise Medical (Us), LLC18
Tisport53
Gunnell, Inc.15
Decided510(k)Device and applicantCode
Mar 1, 2019K180852Manual Wheelchair
Jiangyin Newrise Medical Equipment Co., Ltd., CN
IOR
Nov 14, 2018K181090Invacare® Solara® 3G and Solara® 3G Spree Manual Wheelchairs
Invacare Corporation
IOR
Sep 25, 2018K181795AST Model MA012 and MS019 Rehab Wheelchair
Sichuan Ast Medical Equipment Co., Ltd., CN
IOR
May 17, 2018K173360Athena 190
Medical Rehab Products, LLC
IOR
Nov 16, 2017K170517Merits Model R106/R136 Rehab Wheelchair
Merits Healthcare Industries (Suzhou) Co., Ltd., CN
IOR
Oct 18, 2017K171017Convaid Flyer FL12, FL13, FL14, FL15 and FL16; Convaid Flyer transit FL12T, FL13T, FL14T, FL15T and FL16T
Convaid Products, LLC
IOR
Jul 28, 2017K163352Wheelchair
Kunshan Hi-Fortune Health Products Co., Ltd., CN
IOR
Jun 27, 2017K163432Stellar LEAP
Pdg Product Design Group, Inc., CA
IOR
May 11, 2017K162328Winner Transfer Wheelchair
Winner SG Pte, Ltd., SG
IOR
Apr 17, 2017K162621Invacare Tracer SX5 Manual Wheelchair, Invacare Tracer IV Heavy Duty/Extra Wide Manual Wheelchair
Invacare Corporation
IOR
Mar 24, 2017K170701GEN_2 and GEN_3 Mechanical Wheelchairs
Free Wheelchair Mission
IOR
Dec 28, 2016K162696Kuschall Advance Manual Wheelchair
Invacare Corporation
IOR
Dec 28, 2016K162692Kuschall K-Series Attract Manual Wheelchair
Invacare Corporation
IOR
Dec 28, 2016K162686Kuschall Champion Manual Wheelchair
Invacare Corporation
IOR
Dec 5, 2016K161425APEX Manual Wheelchair
Motion Composites, CA
IOR
Jul 20, 2016K153328SUNCO Mechanical Wheelchair, model SKW-9003
Danyang Sunco Machinery Co., Ltd., CN
IOR
May 20, 2016K151492Kudu
R82 A/S, DK
IOR
Mar 31, 2016K152021Pure Tilt
Proactive Comfort, LLC
IOR
Feb 19, 2016K152827Weely Manual Wheelchair
Rupiani, FR
IOR
Feb 3, 2016K152878SUNTEC Mechanical Wheelchair, model ST-WL-1000
Danyang Suntec Auto Parts Co., Ltd., CN
IOR
Jan 5, 2016K152536MyOn HC Manual Wheelchair
Invacare Corporation
IOR
Oct 22, 2015K151893P.R.O. CG Manual Wheelchair
Freedom Designs, Inc.
IOR
Aug 25, 2015K151797Nuocande Plastic Manual Wheelchair Model NKD L07
Ningbo Lecount Medical Technology Co., Ltd., CN
IOR
May 1, 2015K143101Helio A7 Manual Wheelchair, Move Manual Wheelchair
Motion Composites, CA
IOR
Dec 17, 2014K141691GEN_3
Free Wheelchair Mission
IOR
Oct 16, 2014K140023ELEVATION
Pdg Product Design Group, Inc.
IOR
Sep 17, 2014K140416TREKKER, TREKKER TRANSIT
Convaid Products, Inc.
IOR
May 28, 2014K130017VALENTINE STEEL WHEELCHAIR
Valentine Intl. , Ltd., TW
IOR
Feb 25, 2014K130517EZ TRANSPORT CHAIR
Harris Medical, LLC
IOR
Feb 13, 2014K132257MANUAL WHEELCHAIR
Zhejiang Jiafeng Electrical & Mechanial Co., Ltd.
IOR
Jan 31, 2014K133855BREEZY ELEGANCE
Sunrise Medical (Us), LLC
IOR
Dec 5, 2013K130788CAPELLA
Future Mobility Healthcare, Inc., CA
IOR
Nov 12, 2013K130848SHANGHAI PHOENIX MECHANICAL WHEELCHAIR
Shanghai Phoenix Medical Equipment Co., Ltd., CN
IOR
Oct 28, 2013K131336TX WHEELCHAIR CHASSIS
Jcm Seating Solutions, Ltd.
IOR
Sep 24, 2013K131529SHENGGUANG MANUAL WHEELCHAIR
Pingdingshan Shenxing Healthcare Technology Co., L, CN
IOR
Aug 16, 2013K123975QUICKIE & ZIPPIE SERIES
Sunrise Medical
IOR
Aug 9, 2013K123076PROFTHAND MECHANICAL WHEELCHAIR
Harmony Hill International, TW
IOR
Mar 11, 2013K113164DISCOVERY TMAX MANUAL WHEELCHAIR
Otto Bock Healthcare LP
IOR
Dec 21, 2012K120391MR4500 WHEELCHAIR
Wardray Premise, Ltd.
IOR
Dec 19, 2012K120628HELIO
Motion Composites, CA
IOR
Sep 20, 2012K120501CHAMP CHAMP TRANSIT
Convaid Products, Inc.
IOR
May 14, 2012K120077COMED K-SERIES MANUAL WHEELCHAIR
Danyang Comed Healthcare Co., Ltd.
IOR
May 7, 2012K113713GEN_2 MECHANICAL WHEELCHAIR
Free Wheelchair Mission
IOR
Apr 18, 2012K112816ZHENJIANG ASURE MECHANICAL WHEELCHAIR
Zhenjiang Assure Medical Equipment Co., Ltd., TW
IOR
Apr 13, 2012K120032MECHANICAL WHEELCHAIR
Aikin Healthcare Co., Ltd.
IOR
Apr 3, 2012K111636REHAB TNT, REHAB RAM, REHAB MAC, REHAB KIDSTER, BARIATRIC REHAB TNT AND REHAB RAM
Gunnell, Inc.
IOR
Mar 28, 2012K112950JIANGSU HEALTHY WAY MECHANICL WHEELCHAIR
Jiangsu Healthy Medical Equipment Co;Ltd, TW
IOR
Mar 28, 2012K112948JIANGSU HEALTHY WAY MECHANICAL WHEELCHAIR
Jiangsu Healthy Way Medical Equipment Co;Ltd, TW
IOR
Mar 8, 2012K120526YUYUE K2 WHEELCHAIR, YUYUE K4 WHEELCHAIR
Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.
IOR
Aug 12, 2011K111739KIDS ROCK 3 CHAIR
Pride Mobility Products Corp.
IOR

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