Walker, Mechanical
FDA product code ITJ · Class I (low risk) · 21 CFR 890.3825 · Physical Medicine
14510(k) clearances
0PMA approvals
25recalls
GMP exemptexempt from GMP rules
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K833869 | Child's WalkerITJ · Traditional | Kaye Products, Inc. | 11/29/1983SE |
| K833195 | Umbrella WalkerITJ · Traditional | Convaid Products, Inc. | 10/27/1983SE |
| K830784 | Walk N RollITJ · Traditional | Meta-Morris | 05/25/1983SE |
| K830848 | Resi-WalkerITJ · Traditional | Lic-Orthion | 04/05/1983SE |
| K823105 | Resi-WalkerITJ · Traditional | Orthion Corp. | 11/05/1982SE |
| K821404 | Light Weight Aluminum WalkerITJ · Traditional | Manuco Manufacturing Co., Inc. | 05/21/1982SE |
| K820711 | Walk-A-CycleITJ · Traditional | Walk-A-Cycle Division | 04/08/1982SE |
| K811485 | Walker/Crutch BagITJ · Traditional | Fred Sammons, Inc. | 06/16/1981SE |
| K792064 | Delta Rolling Self-Licking WalkerITJ · Traditional | Staricat, Inc. | 10/30/1979SE |
| K790529 | Walking AidITJ · Traditional | Maddak, Inc. | 04/03/1979SE |
| K772049 | Walking AidITJ · Traditional | Guardian Products Co., Inc. | 11/11/1977SE |
| K770417 | AnimatorITJ · Traditional | Kdk Medical Products | 04/15/1977SE |
| K770608 | Walking AidITJ · Traditional | Will Ross Co. | 04/08/1977SE |
| K770166 | Manoy Walking AidITJ · Traditional | Maddak, Inc. | 01/28/1977SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0131-2025 Class II | Brand Name: NOVA ORTHO-MED INC. Product Name: MONARCH ROLLATOR RED Model/Catalog Number:…Firm identified a potential risk for a fall hazard. When the end user is readjusting from the slouched… | Nova Ortho-Med Inc | 08/26/2024Open, Classified |
| Z-0130-2025 Class II | Brand Name: NOVA ORTHO-MED INC. Product Name: MONARCH ROLLATOR PURPLE Model/Catalog…Firm identified a potential risk for a fall hazard. When the end user is readjusting from the slouched… | Nova Ortho-Med Inc | 08/26/2024Open, Classified |
| Z-0129-2025 Class II | Brand Name: NOVA ORTHO-MED INC. Product Name: MONARCH ROLLATOR BLUE Model/Catalog…Firm identified a potential risk for a fall hazard. When the end user is readjusting from the slouched… | Nova Ortho-Med Inc | 08/26/2024Open, Classified |
| Z-2355-2024 Class II | Nitro Glide Knee Walker-offers users recovering from a below-the-knee injury the ability…The tiller separates from the base/front caster assembly. If the knee walker fails, a user may fall and… | Medical Depot Inc. | 06/14/2024Open, Classified |
| Z-2354-2024 Class II | Nitro Glide Knee Walker-offers users recovering from a below-the-knee injury the ability…The tiller separates from the base/front caster assembly. If the knee walker fails, a user may fall and… | Medical Depot Inc. | 06/14/2024Open, Classified |
| Z-0231-2024 Class II | BREG REF 100519-000 WALKER FOLDING WALKER WITH WHEELS Utilized as a walking aid.Due to walkers not meeting product specifications. Walkers were manufactured with misaligned wheels. | Breg Inc | 09/13/2023Open, Classified |
| Z-2445-2023 Class II | DOLOMITE GLOSS ROLLATOR - intended to support during walking and may also serve as a…Premature failure of the seat during use, the plastic eyelets of the folding mechanism of the device's seat… | Invacare Corporation | 06/15/2023Open, Classified |
| Z-0510-2022 Class II | Voyager Rollator-intended as a mechanical walker Model Number: RLEU10xx (RLEU10BL…Wheel spoke may crack causing the wheel to separate from the axle may result in patient injuries, including… | Compass Health Brands (Corporate Office) | 01/10/2022Open, Classified |
| Z-1687-2021 Class II | MyWay Walker Chassis - Product Usage: is intended for use by children already using a…Due to a failure of the welds, the casters detached from the rear legs of the walker. | James Leckey Design Ltd | 03/01/2021Open, Classified |
| Z-1858-2020 Class II | Chest Support for R82 Mustang, Model Numbers: 861810, 861820, 861830; and Rabbit Up…The plastic plug on the chest support for Mustang and Rabbit/Rabbit Up can come loose without use of a tool. | R82 A/S | 03/06/2020Terminated |
| Z-0654-2021 Class II | Star 8 Rolling Walker/Rollator, Items: 4258/ BK(Black)/ BL(Blue)/ DB(Sky Blue)/…Walkers within the identified serial range have the potential for the front fork to unscrew itself from the… | Nova Ortho-Med Inc | 10/07/2019Open, Classified |
| Z-0487-2019 Class II | PremierPro Aluminum Adjustable WalkerThis recall is due to a mandated order from the FDA for stock recovery and return of the imported item. | SVS LLC | 10/01/2018Terminated |
| Z-0304-2017 Class II | 4205 Journey Rolling Walker Product Usage: used to assist people in walkingNova Medical is recalling the Journey Rolling Walker because the screws used to hold the black side support… | Nova Ortho-Med Inc | 10/01/2016Terminated |
| Z-0204-2015 Class II | Transport Rollator with Padded Seat; Large 8-inch wheels with wheel locks (indoor and…The caster may separate completely from the device frame causing injury to user. | Roscoe Medical Inc | 10/01/2014Terminated |
| Z-0416-2015 Class II | MediChoice Dual-Release Folding Walker with 5" wheelProduct wheels may be too loose, too tight, or fall off. | Owens & Minor Distribution, Inc. | 06/25/2014Terminated |
| Z-0142-2015 Class II | DMI Duro-Med Industries Rollator Transport Chair; Wheel Size: 7 1/4"; Overall Width: 23…There have been 5 customer reports of a 501-1018 series DMI Rollator Transport Chair collapsing during use. | Briggs Medical Service Company d.b.a. Mabis | 06/05/2014Terminated |
| Z-1451-2014 Class II | Sit/stand Rolling Walker, SKU/Item Number 66838. Intended for use by those with…Harbor Freight Tools intiaited a recall of Sit/Stand Rolling Walker (SKU/Item Number 66838, sold June 2009… | Central Purchasing LLC DBA Harbor Freight… | 03/27/2014Terminated |
| Z-2014-2012 Class II | Etac Ono Walker, Etac Avant Walker, and Etac Salsa Walker. These products are…The recall has been initiated because there is the potential that users may fall and become injured, with… | Etac Supply Center Ab | 04/06/2012Terminated |
| Z-1704-2012 | Knee walker, one unit per box. Manufacturer Kenstone Metal (Kunshan) Co., LTD. The…Adverse event data prompted testing of device, which revealed that the rod supporting the knee pad was not… | Invacare Corporation | 04/06/2012Terminated |
| Z-3280-2011 | Dual Blue-Release Adult Walkers - Wheeled, and Blue Release Junior Walkers with 5 inch…The firm is conducting a recall/correction of their adult and junior wheeled walkers due to a component… | Invacare Corporation | 03/02/2011Terminated |
| Z-2269-2010 | ESSENTIAL MEDICAL SUPPLY, INC. ENDURANCE HD, BUILT TO LAST, HEAVY DUTY FOUR WHEEL WALKER…Essential Medical Supply, Inc. is recalling W1801B and W1801R Endurance HD Walkers due to recent reports and… | Essential Medical Supply, Inc. | 12/21/2009Terminated |
| Z-1674-2009 | Essential Medical Supply brand Essential Rollator with Loop Hand Brakes, models W1700B…The caster may separate from the frame completely causing injury to the user. | Essential Medical Supply, Inc. | 05/08/2009Terminated |
| Z-0772-2007 | Lumex Walkabout Lite Four-Wheel Rollator, Manufactured for: Graham-Field Health…The caster bolt stem/screw may loosen over time causing the wheel to come off. | Graham Field Atlanta | 04/02/2007Terminated |
| Z-0155-2007 | Access Point Medical-Heavy Duty Rollator with Curved Back (rolling walker), Product Code…The fork component on the wheel of the Rollator can break due to the use of incorrect manufacturing material… | Access Point Medical LLC | 06/20/2006Terminated |
| Z-0154-2007 | Access Point Medical-Heavy Duty Rollator (rolling walker), Product Code RL12010HD, with…The fork component on the wheel of the Rollator can break due to the use of incorrect manufacturing material… | Access Point Medical LLC | 06/20/2006Terminated |