AffloVest® Mobile Airway Clearance Therapy

The AffloVest Mobile Airway Clearance Therapy is a high-frequency chest wall oscillation (HFCWO) vibratory vest designed to promote airway clearance and improve bronchial drainage by enhancing mobilization of bronchial secretions. It consists of a synthetic polymer vest with four zones of oscillating vibratory motors, a rechargeable lithium-ion battery, and a wired controller allowing physicians to adjust oscillation intensity. The device is intended for pediatric (≥6 months) to geriatric patients where external thorax manipulation is the physician's treatment choice.

The subject device differs from the predicate in two technological characteristics: (1) connectivity via Wi-Fi and Bluetooth for data upload and over-the-air updates, shared with Reference Device 1; and (2) a broader garment size range (16–75 inches versus the predicate's 33–53 inches), shared with Reference Device 2. Treatment frequencies are higher (24–32 Hz) than the predicate (22–27 Hz), but resulting forces are similar or lower due to motor design differences.

Testing per IEC 60601-1, 60601-1-6, 60601-1-11 (electrical safety), IEC 60601-1-2 and 60601-4-1 (electromagnetic compatibility). Performance testing included weight verification, battery life, motor speed, comfort testing, motor life testing, software verification and validation, and cybersecurity verification and validation.

Substantial equivalence is established because the subject device has the same intended use, regulatory classification (21 CFR 868.5665, Powered Percussor), and product code (BYI) as the predicate device. Technological differences (connectivity and size range) do not raise new questions of safety or effectiveness, as demonstrated by performance testing that shows similar or lower applied forces and broader size availability matching competitive offerings without compromising safety.