Wave Electrode (AE02-60); Wave Electrode (AE02-50)

The Wave Electrode is an active surface electromyographic (EMG) electrode that detects electrical signals from residual muscles in amputated upper limbs and transmits proportional output signals to control myoelectric prosthetic hands. It is used exclusively for external prosthetic fittings of the upper limbs in adults with mono- or bilateral amputations starting at the transradial level, and is compatible only with Adam's Hand prosthetics.

The Wave Electrode outputs a 0–5V analog signal proportional to the instantaneous EMG envelope, operates at 6–8.4 VDC with 2 mA power consumption, has dimensions of 27 × 18 × 8 mm, operates over 0–40°C, and uses a 90–450 Hz frequency bandwidth. It is made of ABS and AISI 316L stainless steel, contains no on-board software or firmware, and does not require a separate battery beyond the one in the prosthesis. The two models differ only in notch filter frequency (50 Hz or 60 Hz).

Electrical safety per IEC 60601-1 and IEC 60601-1-11; electromagnetic compatibility per IEC 60601-1-2; biocompatibility per ISO 10993-5 (cytotoxicity), ISO 10993-10 (skin irritation), and ISO 10993-23 (sensitization).

The Wave Electrode performs the same core function as the predicates—acquiring EMG signals, filtering and amplifying them analogically, and outputting proportional signals to drive a myoelectric prosthetic hand. Although it has slightly lower power requirements, smaller dimensions, and narrower frequency bandwidth than the Dexus predicate, these differences fall within the range of established safe and effective designs and do not introduce new safety or efficacy concerns. The device uses biocompatible materials tested to current ISO standards, employs no programmable electronics (eliminating firmware-related risks), and achieves substantially equivalent performance through equivalent principles of operation and comparable electrical and biocompatibility testing.