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
FCC Part 15 Certified
IEC 62304
IEC 60601-1-1
IEC 60601-1-2
IEC 60601-1-11
IEC 62133
ISO 13485:2016
EN ISO 13485:2016
ISO 26782:2009
ISO 23747:2015
ATS/ERS 2019 Technical Standards
HIPAA Compliance
Compliance program
FDA 21 CFR 820
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FDA Class II Exempt Listing
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