Air Compression Leg Massager (K-705)

The Air Compression Leg Massager (K-705) is a portable, rechargeable, over-the-counter device that simulates kneading and stroking of leg tissue using inflatable pressure cuffs. It is intended to temporarily relieve minor muscle aches and pains and temporarily increase blood circulation to the treated areas in healthy individuals.

The device features a 2-chamber pneumatic compression system with sequential inflation modes at three pressure levels (120, 170, and 210 mmHg with ±25 mmHg error range), 15-minute treatment duration, and microprocessor control. It includes integrated warming (35–41°C) and vibration (150 Hz ±15 Hz) features. The controller houses a rechargeable 3.7V 2500mAh battery and is housed in molded ABS plastic, while leg wraps use nylon polyester material.

ISO 10993-5 (cytotoxicity), ISO 10993-10 (skin sensitization), ISO 10993-23 (skin irritation); IEC 60601-1 (general electrical safety), IEC 60601-1-2 (EMC), IEC 60601-1-11 (home healthcare environment); IEC 62133-2 (lithium battery safety).

The subject device has identical intended use and same technological application area, chamber count, air pressure levels, and treatment time as the primary predicate (EMK-701). Although minor differences exist in power source, dimensions, weight, sleeve materials, and operational specifics (e.g., inflation/deflation timing), these do not raise safety or efficacy concerns because the core compression mechanism, pressure ranges, and sequential inflation principle are substantially similar. Performance testing confirms biocompatibility, electrical safety, and software validation equivalent to the predicate, supporting that functional performance is comparable for the intended indication.