Data / Medical devices / Blanket, Neonatal Phototherapy
Blanket, Neonatal Phototherapy (PDH): 3 FDA-registered makers in 2 countries
3 establishments in 2 countries are registered with the FDA to make Blanket, Neonatal Phototherapy (product code PDH, Class 2, 21 CFR 880.5700). 1 of them has a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 2 510(k) clearances under this code, the latest on June 12, 2015, and lists 1 recall event (0 Class I). FDA data exported November 2, 2026.
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- Product code
- PDH
- Device class
- 2
- Regulation
- 880.5700
- Medical specialty
- General Hospital
Makers by country
| Country | Makers |
|---|---|
| United States | 2 |
| China | 1 |
Makers of Blanket, Neonatal Phototherapy
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 |
|---|---|---|---|---|---|---|---|---|
| Salter Labs | El Paso, TX, United States | Specification developer | 1 | June 12, 2015 | 0 | 0 | 0 | api.fda.gov |
| Advanced Instrumentations, Inc. | Miami, FL, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ningbo Risenmed Technology Co.,ltd. | Ningbo Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated June 12, 2015. 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.