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

Wheelchair, Mechanical

Regulation 890.3850

21510(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

DateFirm and productCodeLinked 510(k)
Sep 24, 2021TiSport, Llc
Permobil TiLite, Models: Aero Z, and ZRA
Open, Classified
IORK990358
Sep 11, 2018TiSport, Llc
TiLite X-Short anti-tip tubes, models TRA, AERO T, ZRA, AERO Z, 2GX, AERO X, Twist, and AERO R, a component of the TiLite wheelchair (anti-tip extension for manual wheelchairs). Product Usage: The
Terminated
IORK023606
K072311 +1
Jul 25, 2016Sunrise Medical (US) LLC
Quickie Q7 wheelchair. Model EIR4 Physical Medicine. The Quickie Q7 series of wheelchair's intended use is to provide mobility to persons limited to a sitting position.
Terminated
IORK123975
Jan 27, 2016Karman Healthcare Inc
Karma Flexx Wheelchair Manual Wheelchair.
Terminated
IORK002167
Aug 26, 2015Sunrise Medical (US) LLC
Quickie IRIS Wheelchair. model EIZ4-2 in combination with option code 183M02 - MONO Backrest system with Dynamic Backrest option. Provide mobility to persons limited to a sitting position.
Terminated
IORK123975
Aug 26, 2015Sunrise Medical (US) LLC
Zippie IRIS Wheelchair. model EIZ5A in combination with option code 188M02 - MONO Backrest system with Dynamic Backrest option. Provide mobility to persons limited to a sitting position.
Terminated
IORK123975
Jan 27, 2015Sunrise Medical (US) LLC
Quickie Q7 Adult Rigid Wheelchair Model EIR4.
Terminated
IORK123975
Jan 27, 2015Sunrise Medical (US) LLC
Zippie Zone Pediatric Rigid Wheelchair Model EIRZ1.
Terminated
IORK973673
Dec 16, 2014Snug Seat Inc
Crocodile (size 3) are two-armed, wheeled walking aids, used by children with disabilities. Product Usage: The Crocodile is a walking aid for children with disabilities, who need supplementary assista
Terminated
IORK934560
Nov 14, 2014Silver Star Brands
Transport Chair and Rollator in 1, Model HE21630011 Burgundy and HE21630011 Blue. This is a walker/rolling chair. Used to assist injured and infirm people to walk or be ambulatory.
Terminated
IORNone listed
Sep 24, 2014Pdg Product Design Group Inc
Fuze Manual Tilt Wheelchair. Fuze T50, Fuze T20 and Fuze T50 Jr
Terminated
IORK063736
Jan 8, 2014Invacare Corporation
Tracer IV wheelchairs, Heavy duty manual wheel chair, 24" seat width, 450 lbs. weight capacity. Distributed by Invacare, Elyria, OH 44035 For transportation to accomplish necessary tasks of daily liv
Terminated
IORNone listed
Dec 5, 2013Sunrise Medical (US) LLC
Sunrise Brand Zippie Voyage, Chair with Casters, Early Intervention Device (Stroller), Model: EIZ14; Product is manufactured and distributed by Sunrise Medical (US) LLC., Fresno, CA. Used by a pers
Terminated
IORK123975
Feb 13, 2013CHENICA INC.
Chenica Gunnell Rehab Series of Wheelchairs (GRSW); Mechanical Wheelchair, Sold as Rehab Tough and Tilt (TNT), Rehab Recline and Mobility (RAM), Rehab Kidster (Kidster). Provide mobility to individu
Terminated
IORK111636
Feb 4, 2013Invacare Corporation
Solara 3G Custom Manual Wheelchair Product Usage: To provide mobility to a person restricted to a sitting position.
Terminated
IORK984447
Jul 31, 2012Sunrise Medical (US) LLC
Padded Swing Away Arm Rest with Receiver; Uses on wheelchair models: Quickie Q7 (EIR4), GT (EIR3), GTi (EIT4) and Zippie Zone (EIRZ1). Product Usage: To empower physically challenged persons by provi
Terminated
IORK973673
Feb 24, 2012Sunrise Medical (US) LLC
Sunrise Medical Zippie TS wheelchair To empower physically challenged person by providing a means or mobility.
Terminated
IORK973673
Jan 25, 2012Gunnell, Inc.
Gas cylinders used in Gunnell manual wheelchairs with dynamic recline feature, including: Rehab MAC Platform Chair Product Usage: The purpose of these wheelchairs is to provide mobility to individua
Terminated
IORNone listed
Jan 25, 2012Gunnell, Inc.
Gas cylinders used in Gunnell manual wheelchairs with dynamic recline feature, including: Bariatric Rehab Tough & Tilt (BTNT) Product Usage: The purpose of these wheelchairs is to provide mobility
Terminated
IORNone listed
Jan 25, 2012Gunnell, Inc.
Gas cylinders used in Gunnell manual wheelchairs with dynamic recline feature, including: Rehab RAM Product Usage: The purpose of these wheelchairs is to provide mobility to individuals limited to a
Terminated
IORNone listed
Jan 25, 2012Gunnell, Inc.
Gas cylinders used in Gunnell manual wheelchairs with dynamic recline feature, including: Rehab Tough and Tilt (TNT). Product Usage: The purpose of these wheelchairs is to provide mobility to indiv
Terminated
IORNone listed
Jan 25, 2012Gunnell, Inc.
Gas cylinders used in Gunnell manual wheelchairs with dynamic recline feature, including: Rehab Kidster( Kidster). Product Usage: The purpose of these wheelchairs is to provide mobility to individu
Terminated
IORNone listed
Sep 7, 2011TiSport, Llc
TiLite ZR and ZRA Series 2 are mechanical wheelchairs. Devices are sold under brand name TiLite. The TiLite ZR had a model catalog number of Z2FS1. The TiLite ZRA has a model catalog number of Z2F
Terminated
IORK990358
Dec 28, 2010Sunrise Medical Inc
Manual Wheelchairs with Transit System Option, Model: Quickie LXI (EILXI), Product is manufactured and distributed by Sunrise Medical, Inc. Fresno, CA Intended to provide mobility to persons restri
Terminated
IORK973673
Nov 25, 2009Invacare Corporation
Kuschall K Junior Manual wheelchair
Terminated
IORK982336
Aug 19, 2008Medline Industries Inc
Bariatric Wheelchair, 28" Wide and 20" Deep Seat, 700 lb. Weight Capacity; Manufactured in Taiwan for Medline Industries, Inc., Mundelein, IL 60060 USA; Item #MDS809800 comes with Removable Desk-Leng
Terminated
IORK051302
Aug 19, 2008Medline Industries Inc
Bariatric Wheelchair, 26" Wide and 20" Deep Seat, 700 lb. Weight Capacity; Manufactured in Taiwan for Medline Industries, Inc., Mundelein, IL 60060 USA; Item #MDS809700 comes with Removable Full-Leng
Terminated
IORK051302
Aug 19, 2008Medline Industries Inc
Bariatric Wheelchair, 24" Wide and 19" Deep Seat, 600 lb. Weight Capacity; Manufactured in Taiwan for Medline Industries, Inc., Mundelein, IL 60060 USA; Item #MDS809600 comes with Removable Desk-Leng
Terminated
IORK051302
Dec 19, 2007Freedom Designs Inc
Freedom Designs TriPod w/Anti tipper Manual Wheelchair, Models Numbers: TriPod, Tripod LT and TriPod Pediatric LT with Trailing Anti-Tipper-Caster-Axle Link, Freedom Designs Incorporated, Simi Valley,
Terminated
IORK060926
Sep 20, 2006Invacare Corporation
Solara Spree XT (SPRXT) manual wheelchair.
Terminated
IORK012370
Sep 20, 2006Invacare Corporation
Solara Spree GT manual wheelchair.
Terminated
IORK012370
Sep 20, 2006Invacare Corporation
Solara 2G manual wheelchair.
Terminated
IORK012370
Sep 6, 2006Invacare Corporation
Kuschall''s K3/K4 Series of Manual Wheelchair, Model Airlite.
Terminated
IORK982336
Mar 22, 2005Cypress Medical Products, Ltd.
Manual Mechanical Wheelchair, 22'' seat, , maximum patient weight: 350 lbs.; Marketed by McKesson Corporation, McKesson Medical-Surgical, Richmond, VA 23228, Made in China; the wheelchairs were sold i
Terminated
IORK002670
Mar 22, 2005Cypress Medical Products, Ltd.
Manual Mechanical Wheelchair, 20'' seat, , maximum patient weight: 350 lbs.; Marketed by McKesson Corporation, McKesson Medical-Surgical, Richmond, VA 23228, Made in China; the wheelchairs were sold i
Terminated
IORK002670
Mar 22, 2005Cypress Medical Products, Ltd.
Manual Mechanical Wheelchair, 24'' seat, , maximum patient weight: 450 lbs.; Marketed by McKesson Corporation, McKesson Medical-Surgical, Richmond, VA 23228, Made in China; the wheelchairs were sold i
Terminated
IORK002670
Mar 22, 2005Cypress Medical Products, Ltd.
Manual Mechanical Wheelchair, 16'' seat, , maximum patient weight: 250 lbs.; Marketed by McKesson Corporation, McKesson Medical-Surgical, Richmond, VA 23228, Made in China; the wheelchairs were sold i
Terminated
IORK002670
K002671
Mar 22, 2005Cypress Medical Products, Ltd.
Manual Mechanical Wheelchair, 18'' seat, , maximum patient weight: 250 lbs.; Marketed by McKesson Corporation, McKesson Medical-Surgical, Richmond, VA 23228, Made in China; the wheelchairs were sold i
Terminated
IORK002670
K002671
Jul 20, 2004Bock,Otto,Orthopedic Ind,Inc
Otto Bock Kimba Plus Pediatric Tilt-in-Space Postural Mobility Systems (Strollers), Product Numbers HR32571001-012, HRK3269=06-027_X, R32651001-012, HRK3283=01-026_X, HRK3269=01-026_X, HRK3283=02-026_
Terminated
IORNone listed
May 14, 2003Action Products Incorporated
Twister(tm) Cube Back-Cane Short, a wheelchair back seat support strap, part number WPHS.
Terminated
IORNone listed

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