Perlove High-power mobile DR obtains FDA510(k) approval!

At present, more than 210 million people have been diagnosed with Covid-19 abroad, and the international epidemic situation is still severe. Perlove Medical, as the United Nations preferred supplier of anti-epidemic materials, has been contributing its strength to the production and supply of global anti-epidemic products!

01

International certification

Perlove Medical’s high-power mobile DR has not only obtained the EU CE certification. On August 25, FDA certification also made key progress-obtaining FDA510(k) approval, and obtaining FDA approval for high-power mobile DR demonstrates the hard core strength of Perlove medical imaging products, and also marks that Perlove Medical will become more countries in the world Provide more powerful support for the anti-epidemic work!

Q: What is the US FDA certification?

The US Food and Drug Administration (Food and Drug Administration) is referred to as FDA. The FDA’s responsibility is to ensure the safety of food, cosmetics, drugs, biological agents, medical equipment, and radiological products produced or imported in the United States. Medical equipment and radiological products must be registered and approved by the FDA in the United States.FDA is known for its authority and strict audit standards. The FDA-certified products not only show the outstanding strength of the company and the reliable product quality, but also more security in terms of safety.

Q: What is the EU CE certification?

Any country’s products must be CE certified to enter the European Union and European Free Trade Zone for sale, and the CE mark should be affixed to the product. CE certification of product testing and technical document review is also very stringent. The product must first pass the safety, health and environment checks and obtain a qualified test report. Then compile a full set of technical documents in accordance with the EU medical device regulations, and the final CE certificate can only be obtained after the notified body has passed the review

.02

 High power hard core boost

Perlove Medical has been deeply involved in the mobile DR market for decades. Relying on its own research and development advantages, combined with the global new crown epidemic prevention and control needs, in 2021, it will launch a high-power mobile DR suitable for a variety of clinical needs.

◆ 50kW high power for more patients

The 50kW high-power tube can stably output high-quality X-rays and ensure high-quality image quality. Especially for obese people in Europe and the United States, high-power mobile DR can easily obtain clear clinical images.

◆ Dual-motor drive, more agile movement

It adopts dual-wheel and dual-drive design, which can move fast and move smoothly, and inspection work can be carried out quickly. It can meet the special use of isolation ward, ICU, emergency room, respiratory department and disease control center, saving precious time for saving patients.

◆ New energy storage technology, more stable performance

The high-power mobile DR adopts a new energy storage technology with fast charging speed, and the shortest time to charge to the rated capacity is about ten minutes, saving lives and racing against time!

 Perlove,World of love

“Working together, fighting the epidemic without borders” Perlove Medical, as a national brand of medical equipment in China, has provided anti-epidemic imaging equipment to more than 100 countries around the world.                                                                        

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