Air Compression Leg Massager (UM605, UM606, UM607, UM608,UM609,UM610, UM611, UM617)

The Air Compression Leg Massager is a portable, rechargeable device that temporarily relieves mild muscle pain and discomfort in the legs (calves) and temporarily increases blood circulation. It simulates kneading and stroking of tissues using inflatable pressure cuffs controlled by an electronic pump unit, and is intended for over-the-counter use in people who are in good health.

The subject device uses sequential compression with a 2-chamber inflatable garment, pneumatic control via electronically controlled air pump, and microprocessor control. It operates at three pressure levels (120, 170, 210 mmHg) with adjustable timer settings (15, 30, 45 minutes) and produces noise below 55 dB. Key differences from the predicate include a smaller, lighter design (370g vs 2.0 kg) powered by internal rechargeable lithium battery (3.7V, 2000mAh) rather than external AC adapter, and application limited to the calf versus both feet and calves.

IEC 60601-1 (general medical electrical safety), IEC 60601-1-2 (electromagnetic compatibility), IEC 60601-1-11 (home healthcare use), IEC 62133-2 (lithium battery safety), ISO 10993-5 (cytotoxicity), ISO 10993-10 (sensitization), and ISO 10993-23 (irritation).

The subject device is substantially equivalent because it uses the same fundamental technology (sequential compression via pneumatic cuffs and microprocessor control), maintains identical air pressure levels and timing parameters (inflation, keep, deflation times), applies the same compression mode to the calf (equivalent to Mode 2 of the predicate), and complies with the same safety and biocompatibility standards. While the subject device is smaller, lighter, and uses internal battery power, these physical and power-source differences do not affect safety or effectiveness since the device still meets all relevant electrical and performance standards.