Data / Medical devices / Infant Supine Sleep System
Infant Supine Sleep System (QTG): 3 FDA-registered makers in 2 countries
3 establishments in 2 countries are registered with the FDA to make Infant Supine Sleep System (product code QTG, Class 2, 21 CFR 880.5690). 1 of them has a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 1 510(k) clearance under this code, the latest on March 30, 2023, and lists 2 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- QTG
- Device class
- 2
- Regulation
- 880.5690
- Medical specialty
- General Hospital
Makers by country
| Country | Makers |
|---|---|
| United States | 2 |
| China | 1 |
Makers of Infant Supine Sleep System
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 |
|---|---|---|---|---|---|---|---|---|
| Happiest Baby, Inc. | Los Angeles, CA, United States | Complaint file establishment, Specification developer | 1 | March 30, 2023 | 0 | 2 | 0 | api.fda.gov |
| Ivy Technology | Jeffersontown, KY, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jetta (china) Industries Co., Ltd | Guangzhou City Guangdong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated March 30, 2023. 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.