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)
Top companies in ITJ
| Company | 510(k)s | Recalls |
|---|---|---|
| Nova Ortho-Med Inc | 0 | 5 |
| Invacare Corporation | 0 | 3 |
| A & E Industries, Ltd. | 0 | 2 |
| Access Point Medical LLC | 0 | 2 |
| Essential Medical Supply, Inc. | 0 | 2 |
| Maddak, Inc. | 2 | 0 |
| Medical Depot Inc. | 0 | 2 |
| Medline Industries, LP | 0 | 2 |
| Breg Inc | 0 | 1 |
| Briggs Medical Service Company d.b.a. Mabis | 0 | 1 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 5, 2026 | Medline 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 |
ITJ | None listed |
| Oct 5, 2026 | Medline 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 |
ITJ | None listed |
| Oct 17, 2024 | Nova 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 |
ITJ | None listed |
| Oct 17, 2024 | Nova 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 |
ITJ | None listed |
| Oct 17, 2024 | Nova 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 |
ITJ | None listed |
| Jul 12, 2024 | Medical 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 |
ITJ | None listed |
| Jul 12, 2024 | Medical 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 |
ITJ | None listed |
| Nov 3, 2023 | Breg Inc BREG REF 100519-000 WALKER FOLDING WALKER WITH WHEELS
Utilized as a walking aid. Open, Classified |
ITJ | None listed |
| Aug 23, 2023 | Invacare 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 |
ITJ | None listed |
| Jan 10, 2022 | Compass 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 |
ITJ | None listed |
| Mar 1, 2021 | James Leckey Design Ltd MyWay Walker Chassis - Product Usage: is intended for use by children already using a supportive walking device. Open, Classified |
ITJ | None listed |
| Mar 6, 2020 | R82 A/S Chest Support for R82 Mustang, Model Numbers: 861810, 861820, 861830; and Rabbit Up, Model Numbers: 869810, 869820, 869830 Terminated |
ITJ | None listed |
| Oct 7, 2019 | Nova Ortho-Med Inc Star 8 Rolling Walker/Rollator, Items: 4258/ BK(Black)/ BL(Blue)/ DB(Sky Blue)/ PL(Purple)/ RD(Red) Open, Classified |
ITJ | None listed |
| Oct 1, 2018 | SVS LLC PremierPro Aluminum Adjustable Walker Terminated |
ITJ | None listed |
| Oct 24, 2016 | Nova Ortho-Med Inc 4205 Journey Rolling Walker
Product Usage: used to assist people in walking Terminated |
ITJ | None listed |
| Nov 20, 2014 | Owens & Minor Distribution, Inc. MediChoice Dual-Release Folding Walker with 5" wheel Terminated |
ITJ | None listed |
| Nov 12, 2014 | Roscoe 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 |
ITJ | None listed |
| Oct 28, 2014 | Briggs 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 |
ITJ | None listed |
| Apr 10, 2014 | Central 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 |
ITJ | None listed |
| Jul 14, 2012 | Etac 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 |
ITJ | None listed |
| Jun 5, 2012 | Invacare 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 |
ITJ | None listed |
| Sep 27, 2011 | Invacare 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 |
ITJ | None listed |
| Aug 25, 2010 | Essential 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 |
ITJ | None listed |
| Jul 20, 2009 | Essential 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 |
ITJ | None listed |
| May 5, 2007 | Graham Field Atlanta Lumex Walkabout Lite Four-Wheel Rollator, Manufactured for: Graham-Field Health Products, Atlanta, Georgia 30360. Terminated |
ITJ | None listed |
| Nov 7, 2006 | Access 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 |
ITJ | None listed |
| Nov 7, 2006 | Access 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 |
ITJ | None listed |
| Aug 24, 2006 | A & 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 |
ITJ | None listed |
| Aug 24, 2006 | A & E Industries, Ltd. Guardian Walker, Models 30751W, 30757W, 30758W, Made in China by A&E Machinery Industry Co., Ltd. Terminated |
ITJ | None listed |
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