Safety
Our Commitment to Safety
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:
- ANSI/AAMI ES60601-1:2005 + A1:2012. Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance.
- IEC 60601-1:2005 + A1:2012. Medical electrical equipment - Part 1: General requirements for basic safety and essential performance.
- EN60601-1:2006 +A1:2013. Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
Biocompatibility:
The Flowpresso patient contact materials were verified in accordance with the following standards:
- SO 10993-5, Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity.
- SO 10993-10, Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization.
- ISO 10993-10, Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization.
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.
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