Snoo Smart Sleeper
The SNOO Smart Sleeper bassinet plus the SNOO Sleep Sack are jointly intended to facilitate a supine position during sleep. Infants who are placed in a supine sleep position are at lower…
Infant Supine Sleep System
Which Manufacturers in China Make This?
The one Chinese manufacturer registered for this device type is based in Guangdong. 1 is a contract manufacturer.
- Jetta (China) Industries Co., Ltd. Guangdong, contract manufacturer
What Is It?
An infant supine sleep system is a device intended to facilitate a supine position during sleep for use in infants that are not yet able to roll over consistently. Infants placed in a supine sleep position are at lower risk of sudden infant death syndrome (SIDS) or sudden unexpected infant death (SUID).
How Is QTG Classified?
Infant Supine Sleep System is FDA product code QTG, Class 2, 21 CFR 880.5690.
How Does It Reach the US Market?
A 510(k) premarket notification is required before it is sold in the United States: the applicant shows the device is substantially equivalent to one already on the market. No clearance under this code names a Chinese applicant. A registration is not a clearance: the plants above are set up to make it, and the 510(k) it is sold under is held by whoever files it, often the brand.
What Has Gone Wrong With It?
The FDA has recorded 3 recalls under this product code since 2024. None was by a company in China. The root causes the FDA records most often are Device Design (2) and Reprocessing Controls (1).
A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.
Name
Record