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Panels › Physical Medicine › Product code ITJ · Class 1

Walker, Mechanical

Regulation 890.3825

0510(k)s in 12 months (14 all time)
2recalls in 12 months (29 all time)
0recalls that name a 510(k)
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Top companies in ITJ

Company510(k)sRecalls
Nova Ortho-Med Inc05
Invacare Corporation03
A & E Industries, Ltd.02
Access Point Medical LLC02
Essential Medical Supply, Inc.02
Maddak, Inc.20
Medical Depot Inc.02
Medline Industries, LP02
Breg Inc01
Briggs Medical Service Company d.b.a. Mabis01
DateFirm and productCodeLinked 510(k)
Oct 5, 2026Medline Industries, LP
Rollator, Bariatric, Basic Steel, Blue, mechanical walker with four legs and a metal frame intended for medical purposes to provide moderate weight support while walking, Product Number MDS86800XWBS
Open, Classified
ITJNone listed
Oct 5, 2026Medline Industries, LP
Rollator, Bariatric, Basic Steel, Burgundy, mechanical walker with four legs and a metal frame intended for medical purposes to provide moderate weight support while walking, Product Number MDS86800XW
Open, Classified
ITJNone listed
Oct 17, 2024Nova Ortho-Med Inc
Brand Name: NOVA ORTHO-MED INC. Product Name: MONARCH ROLLATOR RED Model/Catalog Number: 4329RD Product Description: ROLLING WALKER MOBILITY AID
Open, Classified
ITJNone listed
Oct 17, 2024Nova Ortho-Med Inc
Brand Name: NOVA ORTHO-MED INC. Product Name: MONARCH ROLLATOR PURPLE Model/Catalog Number: 4329PL Product Description: ROLLING WALKER MOBILITY AID
Open, Classified
ITJNone listed
Oct 17, 2024Nova Ortho-Med Inc
Brand Name: NOVA ORTHO-MED INC. Product Name: MONARCH ROLLATOR BLUE Model/Catalog Number: 4329BL Product Description: ROLLING WALKER MOBILITY AID
Open, Classified
ITJNone listed
Jul 12, 2024Medical Depot Inc.
Nitro Glide Knee Walker-offers users recovering from a below-the-knee injury the ability to remain mobile and glide through their daily activities. Model: 791RD (Red)
Open, Classified
ITJNone listed
Jul 12, 2024Medical Depot Inc.
Nitro Glide Knee Walker-offers users recovering from a below-the-knee injury the ability to remain mobile and glide through their daily activities. Model: 791BL (Blue)
Open, Classified
ITJNone listed
Nov 3, 2023Breg Inc
BREG REF 100519-000 WALKER FOLDING WALKER WITH WHEELS Utilized as a walking aid.
Open, Classified
ITJNone listed
Aug 23, 2023Invacare Corporation
DOLOMITE GLOSS ROLLATOR - intended to support during walking and may also serve as a resting seat. Model Number(s): 1654807 - DOLOMITE GLOSS 680 ROLLATOR 1655081 - DOLOMITE GLOSS 600 ROLLATOR 1655082
Open, Classified
ITJNone listed
Jan 10, 2022Compass Health Brands (Corporate Office)
Voyager Rollator-intended as a mechanical walker Model Number: RLEU10xx (RLEU10BL, RLEU10PK, RLEU10WT) RLEU10BL Voyager Rollator Cobalt Blue UPC: 815067078066; RLEU10PK Voyager Rollator Rose Gold UP
Open, Classified
ITJNone listed
Mar 1, 2021James Leckey Design Ltd
MyWay Walker Chassis - Product Usage: is intended for use by children already using a supportive walking device.
Open, Classified
ITJNone listed
Mar 6, 2020R82 A/S
Chest Support for R82 Mustang, Model Numbers: 861810, 861820, 861830; and Rabbit Up, Model Numbers: 869810, 869820, 869830
Terminated
ITJNone listed
Oct 7, 2019Nova Ortho-Med Inc
Star 8 Rolling Walker/Rollator, Items: 4258/ BK(Black)/ BL(Blue)/ DB(Sky Blue)/ PL(Purple)/ RD(Red)
Open, Classified
ITJNone listed
Oct 1, 2018SVS LLC
PremierPro Aluminum Adjustable Walker
Terminated
ITJNone listed
Oct 24, 2016Nova Ortho-Med Inc
4205 Journey Rolling Walker Product Usage: used to assist people in walking
Terminated
ITJNone listed
Nov 20, 2014Owens & Minor Distribution, Inc.
MediChoice Dual-Release Folding Walker with 5" wheel
Terminated
ITJNone listed
Nov 12, 2014Roscoe Medical Inc
Transport Rollator with Padded Seat; Large 8-inch wheels with wheel locks (indoor and outdoor use), fold down footrests, ergonomic handles, curved padded backrest and handy wire basket for storage. It
Terminated
ITJNone listed
Oct 28, 2014Briggs Medical Service Company d.b.a. Mabis
DMI Duro-Med Industries Rollator Transport Chair; Wheel Size: 7 1/4"; Overall Width: 23 1/2"; Seat Height: 21 1/4"; Seat Size: 14" x 12 3/4"; Handle Height: 31" - 36"; Width Between Handles: 18"; Weig
Terminated
ITJNone listed
Apr 10, 2014Central Purchasing LLC DBA Harbor Freight Tools
Sit/stand Rolling Walker, SKU/Item Number 66838. Intended for use by those with difficulty walking and weighing 225 lbs. or less.
Terminated
ITJNone listed
Jul 14, 2012Etac Supply Center Ab
Etac Ono Walker, Etac Avant Walker, and Etac Salsa Walker. These products are four-wheeled walkers intended as a walking aid for indoor and outdoor use for persons weighing up to 125 KG.
Terminated
ITJNone listed
Jun 5, 2012Invacare Corporation
Knee walker, one unit per box. Manufacturer Kenstone Metal (Kunshan) Co., LTD. The intended use is to provide additional mobility to individuals who have difficulty walking.
Terminated
ITJNone listed
Sep 27, 2011Invacare Corporation
Dual Blue-Release Adult Walkers - Wheeled, and Blue Release Junior Walkers with 5 inch Fixed Wheels, Model Numbers: 6240-5F and 6240-JR5F. The recalled product is packaged four (4) units per shipping
Terminated
ITJNone listed
Aug 25, 2010Essential Medical Supply, Inc.
ESSENTIAL MEDICAL SUPPLY, INC. ENDURANCE HD, BUILT TO LAST, HEAVY DUTY FOUR WHEEL WALKER for users up to 500 pounds. Model W1801B- Blue, UPC 7 54756 91802 6 all serial numbers. W1801R-Red, UPC 7 547
Terminated
ITJNone listed
Jul 20, 2009Essential Medical Supply, Inc.
Essential Medical Supply brand Essential Rollator with Loop Hand Brakes, models W1700B (Blue) and W1700R (Red), Four Wheel Aluminum Walker/Rollator
Terminated
ITJNone listed
May 5, 2007Graham Field Atlanta
Lumex Walkabout Lite Four-Wheel Rollator, Manufactured for: Graham-Field Health Products, Atlanta, Georgia 30360.
Terminated
ITJNone listed
Nov 7, 2006Access Point Medical LLC
Access Point Medical-Heavy Duty Rollator with Curved Back (rolling walker), Product Code RL12011, with seat, curved backrest, 8'' wheels with locks, maximum capacity 400 lbs.,and wire basket. Manufac
Terminated
ITJNone listed
Nov 7, 2006Access Point Medical LLC
Access Point Medical-Heavy Duty Rollator (rolling walker), Product Code RL12010HD, with seat, backrest, 8'' wheels with locks, maximum capacity 400 lbs.,and wire basket. Manufactured for Access Point
Terminated
ITJNone listed
Aug 24, 2006A & E Industries, Ltd.
Guardian 5 inch Walker Wheel Kits, Model Numbers: 07722-8, 07722G, 07722-5, 07722-8B, 07725. Made in China by A&E Machinery Industry Co., Ltd.
Terminated
ITJNone listed
Aug 24, 2006A & E Industries, Ltd.
Guardian Walker, Models 30751W, 30757W, 30758W, Made in China by A&E Machinery Industry Co., Ltd.
Terminated
ITJNone listed

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