Data / Medical devices / United States / Remedium Healthcare Products
Remedium Healthcare Products: FDA-registered device maker in Northbrook, IL, United States, 1 510(k) clearance
Remedium Healthcare Products is registered with the FDA (registration 3029875292) in Northbrook, IL, United States. It lists 4 device types. The FDA files 1 510(k) clearance under its listings, the newest dated March 23, 2022. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3029875292
- Address
- 40 Skokie Blvd Ste 260, Northbrook, IL, United States, 60062
- Owner or operator
- Remedium Healthcare Products (10088714)
- Roles
- Complaint file establishment, Manufacturer, Specification developer
- First device listed
- November 20, 2023
- Registered through
- 2026
- Brand names listed
- Remedium Homecare Mattress
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Dressing, Wound, Drug | FRO | U | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Dressing, Wound, Hydrophilic | NAC | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Dressing, Wound, Occlusive | NAD | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Mattress, Flotation Therapy, Non-Powered | IKY | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| March 23, 2022 | K210718 | LUOFUCON Extra Silver Gelling Fiber Dressing, LUOFUCON Silver Antibacterial Gelling Fiber Dressing | FRO | Substantially Equivalent | Huizhou Foryou Medical Devices Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Dressing, Wound, Drug
- All makers of Mattress, Flotation Therapy, Non-Powered
- All makers of Dressing, Wound, Hydrophilic
- All makers of Dressing, Wound, Occlusive
Updated March 23, 2022. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.