Data / Medical devices / Holder, Infant Position
Holder, Infant Position (FRP): 3 FDA-registered makers in 1 country
3 establishments in 1 country are registered with the FDA to make Holder, Infant Position (product code FRP, Class 1, 21 CFR 880.5680). 2 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 14 510(k) clearances under this code, the latest on June 12, 2009, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- FRP
- Device class
- 1
- Regulation
- 880.5680
- Medical specialty
- General Hospital
Makers by country
| Country | Makers |
|---|---|
| United States | 3 |
Makers of Holder, Infant Position
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 |
|---|---|---|---|---|---|---|---|---|
| Tucker Designs, Ltd. | Metairie, LA, United States | Manufacturer | 1 | January 26, 1994 | 0 | 0 | 0 | api.fda.gov |
| Tortle Products, LLC | Littleton, CO, United States | Specification developer | 1 | June 12, 2009 | 0 | 0 | 0 | api.fda.gov |
| CHS USA Incorporated | Peachtree City, GA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated June 12, 2009. 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.