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PrO2 device engineering and specifications
Products · Engineering

Specifications & approvals

Product testing, registrations, and certifications—so you can use PrO2 with confidence in clinical and wellness programs.

Detailed specifications

Engineering detail, regulatory listings, interfaces, and metrics—everything documented for procurement and clinical review.

Regulatory Compliance

  • CE Mark
  • FCC part 15 Certified
  • IEC 62304
  • IEC 60601-1-1
  • IEC 60601-1-2
  • IEC 60601-1-11
  • IEC 62133

Battery

  • 3.7v
  • 450 mAH
  • LiPo Certified IEC62133

Charging

  • USB Charging
  • Wireless charging Qi compatible (Optional)

Data Interfaces

  • USB
  • Bluetooth 5.0
  • HIPAA compliant

Pressure Sensor

  • Factory calibrated
  • Waterproof
  • Lifetime accuracy
  • Manufacturing verification

FDA Listing

  • Class II Exempt
  • Registration: 3020967354

Patented Technology

Breathing Metrics

  • Realtime pressure-time graph
  • Fatigue Index Test (FIT)
  • Maximum Inspiratory Pressure (MIP)
  • Maximum Expiratory Pressure (MEP)
  • Sustained Maximum Inspiratory Pressure (SMIP)
  • Sustained Maximum Expiratory Pressure (SMEP)
  • Time

App Support

  • iOS
  • Android
  • Windows (contact us)

Data Security

  • HIPAA-compliant communication
  • Bluetooth 5.0
  • HIPAA-compliant secure storage

For clinical workflows, remote monitoring, and HIPAA-aligned use cases, see our Healthcare.

View all PrO2 products

Cleaning & multi-user use

Keep the device safe when shared across patients, athletes, or family members.

Multiple users

For multiple users, disposable filters must be used to reduce the concern of cross-contamination. PrO2 Health sells compatible filters as well as bite mouthpieces at: pro2health.com/products

Mouthpiece (between each use)

  1. Unscrew the mouthpiece to remove it from the base.
  2. Wipe down with alcohol wipes or wash with soap and water.
  3. Wait until the mouthpiece is fully dry before using again.
  4. Gently hand-tighten the mouthpiece back onto the base.

Device housing

The outer housing is safe to clean with any alcohol- or bleach-based cleaners or wipes.

Important: The device is not waterproof. Do not submerge it in water during cleaning.