Known for more than 25 years of respiratory research, PrO2 Health develops respiratory muscle training technology for clinical care and athletic performance. Its connected system helps providers and researchers measure breathing-muscle function remotely, while patients use it for guided training.
FDA Registration
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CE Mark
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FCC Part 15 Certified
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IEC 62304
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IEC 60601-1-1
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IEC 60601-1-2
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IEC 60601-1-11
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IEC 62133
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ISO 13485:2016
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EN ISO 13485:2016
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ISO 26782:2009
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ISO 23747:2015
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ATS/ERS 2019 Technical Standards
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HIPAA Compliance
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FDA 21 CFR 820
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FDA Class II Exempt Listing
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