Data / Medical devices / Mattress And Bed Deck Cover (Medical Purposes)
Mattress And Bed Deck Cover (Medical Purposes) (QTV): 9 FDA-registered makers in 3 countries
9 establishments in 3 countries are registered with the FDA to make Mattress And Bed Deck Cover (Medical Purposes) (product code QTV, Class 1, 21 CFR 880.6190). 1 of them has a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 1 510(k) clearance under this code, the latest on September 1, 2022, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- QTV
- Device class
- 1
- Regulation
- 880.6190
- Medical specialty
- General Hospital
Makers by country
| Country | Makers |
|---|---|
| United States | 5 |
| China | 2 |
| Vietnam | 2 |
Makers of Mattress And Bed Deck Cover (Medical Purposes)
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Trinity Guardion, Inc. | Batesville, IN, United States | Manufacturer | 1 | September 1, 2022 | 0 | 0 | 0 | api.fda.gov |
| Anzen Health | Chicago, IL, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Compass Health Brands (distribution Center) | Brook Park, OH, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Drive Northpoint, LLC | Palmetto, GA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hebei Junlaole Medical Technology Co.,ltd | Hengshui City Hebei, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Onlycare Inc | Denver, CO, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| QuantMed LifeTech (Shenzhen) Co., Ltd. | ShenzhenCity Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Stevimed Medical Joint Stock Company | Can Giuoc Commune Tay Ninh, Vietnam | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Vien Phat Import Export Service Trading Joint Stock Company | Ben Thanh Ward Ho Chi Minh, Vietnam | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated September 1, 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.