Oral Irrigation Kit
Which Manufacturers in China Make This?
Chinese manufacturers registered for this device type are based in Guangdong and Zhejiang: 4 hold an FDA registration.
- Aimi Health Technology (Guangdong) Co., Ltd. Guangdong
- Hangzhou Yunchi Technology Co., Ltd. Zhejiang, contract manufacturer
- Shenzhen Fox Hunting E-commerce Co., Ltd. Guangdong
- Wenzhou Zuoyou Medical Technoloyg Co., Ltd. Zhejiang, contract manufacturer
What Is This Device?
This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance
How Is OGT Classified?
Oral Irrigation Kit is FDA product code OGT, Class 1, 21 CFR 872.6510.
How Does It Reach the US Market?
The FDA exercises enforcement discretion for this code and does not currently require a premarket submission for devices that meet the conditions it has set for it.
Name
Record