Nova Ortho-Med Inc
North Aurora, IL, US
NOVA ORTHO-MED, INC. appears in FDA device records in North Aurora, IL. FDA records list one 510(k) clearance, no PMA records and one registered establishment. As of , FDA records show 5 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 1 510(k) clearance for Nova Ortho-Med Inc in 2006.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2006 | 1 |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 2085249 | 3002329391 | NOVA ORTHO-MED, INC. | 410 Smoketree Plaza Suite 100, North Aurora, IL 60542 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- ILSAdaptor, Hygiene
- IMLArmrest, Wheelchair
- BZNCart, Emergency, Cardiopulmonary (Excluding Equipment)
- KMNChair And Table, Medical
- INMChair, With Casters
- KNNComponents, Wheelchair
- IMMFootrest, Wheelchair
- FNMMattress, Air Flotation, Alternating Pressure
- FMPProtector, Skin Pressure
- ITJWalker, Mechanical
- IORWheelchair, Mechanical
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0131-2025 | Brand Name: NOVA ORTHO-MED INC. Product Name: MONARCH ROLLATOR RED Model/Catalog Number: 4329RD Product Description: ROLLING WALKER MOBILITY AID | Firm identified a potential risk for a fall hazard. When the end user is readjusting from the slouched seated position to an upright seated position, there is the potential for the movement to cause the backrest to lift out of the backrest holder and disengage from the unit. | Class II | Open, Classified | |
| Z-0130-2025 | Brand Name: NOVA ORTHO-MED INC. Product Name: MONARCH ROLLATOR PURPLE Model/Catalog Number: 4329PL Product Description: ROLLING WALKER MOBILITY AID | Firm identified a potential risk for a fall hazard. When the end user is readjusting from the slouched seated position to an upright seated position, there is the potential for the movement to cause the backrest to lift out of the backrest holder and disengage from the unit. | Class II | Open, Classified | |
| Z-0129-2025 | Brand Name: NOVA ORTHO-MED INC. Product Name: MONARCH ROLLATOR BLUE Model/Catalog Number: 4329BL Product Description: ROLLING WALKER MOBILITY AID | Firm identified a potential risk for a fall hazard. When the end user is readjusting from the slouched seated position to an upright seated position, there is the potential for the movement to cause the backrest to lift out of the backrest holder and disengage from the unit. | Class II | Open, Classified | |
| Z-0654-2021 | Star 8 Rolling Walker/Rollator, Items: 4258/ BK(Black)/ BL(Blue)/ DB(Sky Blue)/ PL(Purple)/ RD(Red) | Walkers within the identified serial range have the potential for the front fork to unscrew itself from the leg. A partially unscrewed fork creates unevenness in the wheelbase, which could cause instability, that if not detected by the user, may result in the front fork falling off the walker. | Class II | Open, Classified | |
| Z-0304-2017 | 4205 Journey Rolling Walker Product Usage: used to assist people in walking | Nova Medical is recalling the Journey Rolling Walker because the screws used to hold the black side support pieces to the frame can become loose over time. This can result in the locking nut coming off and the screw falling out. | Class II | Terminated |
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.
MDM coverage
MDM coverage of this company lists here, newest first. Submit news.
Is this your company?
This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.
Claiming lets Nova Ortho-Med Inc edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.
Data as of , FDA export datePage updated Source: openFDA, public domain