Data / Medical devices / Mattress, Water, Temperature Regulated
Mattress, Water, Temperature Regulated (FOH): 5 FDA-registered makers in 5 countries
5 establishments in 5 countries are registered with the FDA to make Mattress, Water, Temperature Regulated (product code FOH, Class 1, 21 CFR 880.5560). 0 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 6 510(k) clearances under this code, the latest on December 8, 1995, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- FOH
- Device class
- 1
- Regulation
- 880.5560
- Medical specialty
- General Hospital
Makers by country
| Country | Makers |
|---|---|
| Taiwan | 1 |
| China | 1 |
| Germany | 1 |
| Vietnam | 1 |
| United States | 1 |
Makers of Mattress, Water, Temperature Regulated
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 |
|---|---|---|---|---|---|---|---|---|
| R&R Medical Corporation Ltd. | Sanchong District New Taipei, Taiwan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sichuan AST Medical Equipment Co., Ltd | Luzhou City Sichuan, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tec Com Medizintechnik GMBH | Kabelsketal Saxony-Anhalt, Germany | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Yong Yi Viet Nam Co.,ltd | Duc Hoa Commune Tay Ninh, Vietnam | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| ZOLL Circulation, Inc. | San Jose, CA, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated December 8, 1995. 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.