Electric Nasal Aspirator (NASA601,NASA602,NASA603,NASA605,NASA606,NASA608,NASA610)

The Electric Nasal Aspirator is a portable, battery-operated suction device with interchangeable silicone nozzle tips (conical, flat, and angled) designed for intermittent removal of nasal secretions and mucus from children aged 2-12 years in a home environment. It features a motor pump providing negative pressure (52-60 kPa), an LED display with button controls for vacuum pressure adjustment, music and light functions, and charges via USB cable.

The subject device has a higher flow rate (3.3-6.0 L/min vs. 2.5-2.7 L/min), larger battery capacity (2500 mAh vs. 700 mAh), higher power consumption (5W vs. 2W max), and slightly different dimensions and weight than the predicate. It includes two additional components: an air tube and tweezers. However, vacuum pressure range (52-60 kPa), motor type (3.7V DC), music and light functions, biocompatible materials (ABS, PC, silicone), and safety/EMC standards remain identical.

Biocompatibility: ISO 10993-5 (cytotoxicity), ISO 10993-10 (skin sensitization), ISO 10993-23 (skin irritation). Electrical safety and EMC: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11. Battery safety: IEC 62133-2. Performance testing included vacuum pressure, flow rate, noise level, and tubing bending resistance verification.

The devices share identical intended use, patient population, vacuum pressure range, motor type, and core functionality (music/light functions). Although the subject device has higher flow rate and battery capacity, both devices maintain the same 52-60 kPa vacuum pressure range to protect children's nasal mucosa, and performance testing confirmed equivalent safety and effectiveness. The additional components (air tube and tweezers) do not raise safety concerns—the air tube performance was validated through testing, and the tweezers are optional accessories. Both devices comply with identical safety standards and biocompatibility requirements for silicone contact materials.