Intra-Abdominal Pressure Monitoring Device
Who Makes This Device Type in China?
Chinese manufacturers registered for this device type are concentrated in Jiangsu, Guangdong and Zhejiang: 4 hold an FDA registration. 2 are contract manufacturers.
- Changshu Rozer Sterilization Technology Co., Ltd. Jiangsu, contract manufacturer
- Dongguan BAO Kang Dian ZI KE JI Limited Guangdong, contract manufacturer
- Hangzhou Primecare Medical Co., Ltd. Zhejiang, contract manufacturer
- Primecare Medical (Suzhou) Co., Ltd. Jiangsu, contract manufacturer
What Is This Device?
Abdominal intracompartmental pressure monitoring using bladder pressure as a surrogate for abdominal pressure.
How Is PHU Classified?
Intra-Abdominal Pressure Monitoring Device is FDA product code PHU, unclassified.
What Does It Take to Sell It in the United States?
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 Do the Recalls Say?
The FDA has recorded 1 recall under this product code since 2020. None was by a company in China. The root cause the FDA records most often is Device Design (1).
A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.