Safety

Our Commitment to Safety

At Flowpresso, prioritizing safety is not just a policy; it’s a core value that permeates every layer of our company. Recognizing the profound responsibility, we carry in promoting wellness and health, we have committed ourselves to an unwavering dedication to the highest standards of safety. This commitment is evidenced by our rigorous approach to product development, which includes extensive testing phases, adherence to global safety regulations, and continuous monitoring and evaluation of our technology’s performance in real-world clinical settings.

We understand that trust is built on reliability and transparency, and to that end, we have taken extensive lengths to guarantee that every aspect of Flowpresso stands up to the most stringent safety protocals.

FDA cleared Class II Medical Device

Tested & Approved

Electromagnetic Compatibility / Electrical Safety:

Electromagnetic Compatibility/Electrical Safety testing was performed in accordance with the following standards:

Biocompatibility:

The Flowpresso patient contact materials were verified in accordance with the following standards:

Material Heat Testing:

The Flowpresso garment material testing was conducted in accordance with 16 CFR 160 Standard for the Flammability of Clothing Tetiles and the Test Procedure as per 16 CFR 1610.6.  According to the test result, the submitted sample met the calss 1 – normal flammability requirements defined in 16 CFR 1610.

Further testing was conducted in accordance with IEC 60601-2-35:2021 Medical Electrical equipment Part 2-35: Particular requirements for the basic safety and essential performance of heating devices using blankets, pads, and mattresses and intended for heating in medical use showing that all pieces remain well within tolerance of 40ºC.

True innovation walks hand-in-hand with uncompromising safety.  Our relentless pursuit of exellence is matched by our commitment to ensuring every treatment is backed by rigorous testing and adherence to the highest safety standards.

Because at the heart of wellness technology, lies the trust and well-being of our community.

Health Expert

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