SIMEOX 200 Airway Clearance Device

The SIMEOX 200 is a portable airway clearance device that promotes mucus mobilization through high-frequency oscillatory vibrations (6-12 Hz) applied via negative pressure during patient exhalation. Patients inhale ambient air naturally, then exhale into a mouthpiece where the device generates pneumatic vibrations to loosen bronchial secretions, which patients then expectorate by coughing independently. It is intended for home, hospital, and healthcare settings for patients weighing at least 23 kg who can generate a cough.

The device delivers vibration exclusively during exhalation at fixed frequencies (12 Hz for first 8 breaths, 6 Hz for final 2 breaths of each 10-breath cycle). It operates in Standard Mode (adjustable 25-100% power) or ADAPT Mode (auto-regulated power), with Manual or DETECT trigger options. Maximum treatment is 10 cycles (100 exhalations) or 60 minutes. Negative pressure ranges from 0 to -60 cm H₂O with atmospheric (0 cm H₂O) inhalation pressure. The device includes a remote controller and optional lithium-ion battery, with expiratory kits featuring RFID-tracked filters limiting reuse (10 or 25 uses depending on kit version).

ISO 10993-1 (biocompatibility testing for expiratory kit accessories). Comprehensive cybersecurity, wireless, electromagnetic compatibility, electrical, mechanical, and thermal safety testing were conducted. Performance verification testing demonstrated device compliance with pre-specified requirement specifications.

SIMEOX 200 is substantially equivalent to AirPhysio (primary) and SimplyClear (secondary) predicates because all three devices share the identical mechanism of action—high-frequency oscillatory vibration applied to airways during exhalation to loosen and mobilize mucus. All are Class II powered percussors (21 CFR 868.5665) intended for patients with secretion clearance difficulty. SIMEOX 200 operates in exsufflation-only mode with negative pressure (0 to -60 cm H₂O), matching SimplyClear's exsufflation-only operating mode and falling within SimplyClear's -70 cm H₂O range. The oscillation frequencies (6-12 Hz) are within SimplyClear's 0-20 Hz range. Although SIMEOX 200 is narrower in intended use (patients who can cough independently, mouthpiece only), this represents a subset, not a difference in safety or mechanism; nonclinical testing confirmed equivalent performance to predicate specifications across all critical parameters.