Cpr Aid Device Without Feedback
Who Makes This Device Type in China?
5 manufacturers in China hold an FDA registration for this device type, concentrated in Guangdong, Jiangsu and Zhejiang.
- Hangzhou Haizhu MIM Products Co., Ltd. Zhejiang
- Jiangsu Rooe Medical Technology Co., Ltd. Jiangsu
- Saferlife Products Co., Ltd. Guangdong, contract manufacturer
- Shenzhen WAP-Health Technology Co., Ltd. Guangdong
- ZJG Royaltrust MED Co., Ltd. Jiangsu, contract manufacturer
What Is This Device?
A device that performs a simple function such as proper hand placement and/or simple prompting for rate and/or timing of compressions/breathing for the professionally trained rescuer, but offers no feedback related to the quality of the CPR being provided. These devices are intended for use by persons professionally trained in CPR to assure proper use and the delivery of optimal CPR to the victim.
How Is PMK Classified?
Cpr Aid Device Without Feedback is FDA product code PMK, Class 1, 21 CFR 870.5210.
How Does It Reach the US Market?
It is exempt from premarket notification: the manufacturer registers its establishment and lists the device, and no 510(k) is needed before it is sold in the United States.