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How safe is Perifit Care?
Updated over 9 months ago

We are a company specialized in the development of connected medical devices. Perifit Care is perfectly safe, meeting a set of very strict standards and medical requirements.

Bluetooth

Perifit Care communicates with your device using non-ionizing Bluetooth Low Energy (BLE) waves. They are emitted outside of your body from the antenna located at the end of the white wire.

As of now, regulatory bodies (WHO, FDA, FCC, etc.) consider that the BLE waves are too low to be harmful to humans. That is why most advanced wireless healthcare and medical devices use BLE.

In particular, BLE waves are more than 1000 times less powerful than those of the 4G smartphone in your pocket.

Material

Perifit Care is made of medical-grade silicone to prevent allergies and irritations and has been through rigorous safety testing, including stamp, drop, tumble, water, irritation, and heat tests. It is thus suitable for people allergic to latex or carba mix.

Additionally, Perifit Care is:

  • water-resistant: can be placed in a stream of water but should not be submerged or used in the bathtub

  • 100% Estrogenic activity (EA) free

  • 100% Bisphenol A (BPA) free, tested for biocompatibility

  • 100% Phthalate free, tested for biocompatibility

Quality

  • Independent quality testing of each Perifit Care before shipping

  • Barcode traceability throughout production and shipping

Certifications

Perifit Care is:

  • CE marked as a class 1 medical device (CE marking means it conforms with health, safety, and environmental protection standards for products sold within the European Economic Area, Class 1 means it has the lowest perceived risk)

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