Data / Medical devices / United States / Tortle Products, LLC
Tortle Products, LLC: FDA-registered device maker in Littleton, CO, United States, 1 510(k) clearance
Tortle Products, LLC is registered with the FDA (registration 3007842980) in Littleton, CO, United States. It lists 3 device types. The FDA files 1 510(k) clearance under its listings, the newest dated June 12, 2009. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3007842980
- Address
- 9907 Monte Vista Ave, Littleton, CO, United States, 80125
- Owner or operator
- Tortle Product LLC (10029942)
- Roles
- Contract manufacturer, Specification developer
- First device listed
- July 19, 2009
- Registered through
- 2026
- Brand names listed
- Big baby Kit, Small Baby Kit, Tortle Products LLC, Transportle
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Holder, Infant Position | FRP | 1 | Specification developer | accessdata.fda.gov |
| Mattress, Flotation Therapy, Non-Powered | IKY | 1 | Contract manufacturer | accessdata.fda.gov |
| Support, Scrotal, Therapeutic | FQJ | 1 | Contract manufacturer | 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 |
|---|---|---|---|---|---|---|
| June 12, 2009 | K082367 | INFANT SLEEP BEANIE | FRP | Substantially Equivalent | Life Innovations, LLC | accessdata.fda.gov |
Compare with other makers
- All makers of Holder, Infant Position
- All makers of Support, Scrotal, Therapeutic
- All makers of Mattress, Flotation Therapy, Non-Powered
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.