Release date: 2015-01-19
The US Food and Drug Administration (FDA) has published in its published guidelines (draft) that devices that are designed for everyday health and that do not have significant safety concerns (such as fitness tracking devices) can reduce FDA surveillance testing, and these low-risk devices Without invasive features, without laser or radiation characteristics, it does not involve new usability or biocompatibility issues. Naturally, equipment containing UV lamps still requires FDA surveillance.
In the document, “This means that ordinary health tracking new devices can be put into the market faster, and these devices are encouraged to bring consumers with weight management, relaxation and stress management, sleep management, confidence level, etc. Come to a healthier body. But these health tracking devices don't allow claims to have the ability to detect specific diseases, such as not allowing diagnosis and repair of obesity."
Source: nBeta
Manual resuscitator with oxygen tubing, reservoir bag and pressure limiting valve.
With mask or without mask.
With PEEP valve or without PEEP valve.
Reusable Silicone Manual Resuscitator
Disposable PVC Manual Resuscitator
The resuscitator is intended for pulmonary resuscitation. The range of application for each version is:
â— Adult: adults and children.
â— Pediatric: children and infants.
â— Infant: infants and neonates. The resuscitator can be used as normal for continued oxygen supply and assisted ventilation
Manual Resuscitator,Manual Oxygen Resuscitator,Adult Infant Resuscitator,Pulmonary Resuscitator
Hangzhou Trifanz Medical Device Co., Ltd , https://www.cfzmeds.com