Portable mesh nebulizer (JM821)

The JM821 is a portable, handheld mesh nebulizer that uses a piezoelectric transducer vibrating at approximately 114 kHz to aerosolize liquid medications into fine particles for inhalation. It is powered by a 3.7V lithium battery and intended for use with adults and children aged 3 years and older in hospital, home, and sub-acute settings. The device is not intended for use with Pentamidine.

The subject device differs from the predicate (Ivankaca K201397) in vibration frequency (114 kHz vs. 110 kHz), nozzle hole size (18 mm vs. 16 mm), medication capacity (25 ml vs. 8 ml), nebulization rate (≥0.25 ml/min vs. ≥0.2 ml/min), device dimensions and weight, charging interface (Type-C vs. USB), and materials (ABS/PCTG/TPU vs. PVC and others). Both devices use identical ultrasonic vibrating mesh technology, the same 3.7V battery, and operate under identical electrical safety standards.

IEC 60601-1:2005+A1:2012+A2:2020, IEC 60601-1-2:2020, IEC 60601-1-11:2020, ISO 27427:2023, ISO 10993-1/5/10/17/18/23:2018-2021, ISO 18562-1/2/3:2017, and FDA CDRH guidance for nebulizer aerosol characterization (1993). Software verification followed FDA guidance on device software functions, and cleaning validation followed FDA reprocessing guidance.

Although the subject device differs in vibration frequency, nozzle hole size, and medication capacity, aerosol particle characterization testing at 95% confidence level showed no statistically significant differences between the devices in Total Mass, MMAD, GSD, Respirable Fraction, and Respirable Mass parameters in both adult and pediatric modes across three test drugs. The subject device passed identical electrical safety and EMC standards as the predicate and demonstrated equivalent biocompatibility. The minor design variations (size, weight, materials, charging port) do not raise new safety or effectiveness issues, and the expanded pediatric age claim (3 years vs. 4 years) is supported by other legally marketed devices claiming similar or younger ages.