Air compression massager (ACM-PLUS-A1, ACM-PLUS-A2, ACM-PLUS-A3, ACM-PLUS-A4, ACM-PLUS-A5, ACM-PLUS-A6)

The Air Compression Massager (ACM-PLUS series, six models) is a powered inflatable tube massager intended to temporarily relieve minor muscle aches and pains and temporarily increase circulation to treated areas. It uses sequential inflation of pressure cuffs to simulate manual kneading and stroking, operates on a rechargeable lithium-ion battery, and can be controlled via on-device buttons or a Bluetooth-enabled mobile app.

The device features a compressor and valve system that sequentially inflates five segments, pressure range of 0–110 mm Hg with 15 selectable pressure levels (40–110 mm Hg in 5 mm Hg increments), treatment time adjustable from 15–60 minutes, five massage modes (Fatigue Relief, Training Activation, Workout Recovery, Overall Relaxation, Deep Care), and Bluetooth connectivity. It differs from predicates in battery type (7.3V rechargeable Li-ion vs. AC-powered), control unit dimensions, contact surface materials (nylon/TPU/polyester blend vs. nylon with polyurethane laminate), and pressure level granularity.

ANSI/AAMI ES60601-1 (electrical safety), IEC 60601-1-2:2020 (EMC), IEC 60601-1-11:2020 (home healthcare environment), ISO 10993-1, 10993-5, 10993-10, and 10993-23 (biocompatibility), ANSI/AAMI IEC 62304 (software lifecycle), IEC 62133-2 (lithium battery), and IEEE/ANSI/USEMCSC C63.27-2021 (wireless coexistence).

The subject device has identical intended use (temporary relief of minor muscle aches/pains and circulation increase) and substantially similar technological approach (compressor-valve system with sequential chamber inflation) to the primary predicate (Normatec Elite K240122). Although specifications differ (power source, dimensions, pressure level intervals, contact materials, massage mode variations), all differences operate within the same safety and performance envelope: the output pressure range is identical (0–110 mm Hg), all devices conform to the same electrical safety standard (ES60601-1), biocompatibility testing confirms material safety, and the massage sequences of the subject device map to established predicate modes. Testing confirms no new safety or effectiveness questions arise from these design variations.