Remote Wave Electrode (AE03-50); Remote Wave Electrode (AE03-60)

The Remote Wave Electrode is an active analog electrode that detects surface electromyographic (EMG) signals from residual muscles in amputees to control prosthetic hands. It is compact, low-power, and provides real-time output proportional to detected muscle activation. The device is intended exclusively for external prosthetic fittings of the upper limbs in adolescents and adults with unilateral or bilateral amputations.

The Remote Wave Electrode has the same core characteristics as the predicate Wave Electrode but differs in physical design: it features metallic contact plates (AISI 316L steel) located outside the electrode case and connected via three shielded cables, versus the predicate's integrated contact design. Both produce 0–5V analog output, operate at 6–8.4V DC with 2mA power, have 90–450 Hz frequency bandwidth, and operate at 0°C–40°C. Dimensions are slightly different: 27×18×7mm (subject) versus 27×18×8mm (predicate).

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

The Remote Wave Electrode is substantially equivalent to the predicate Wave Electrode (K242326) because both acquire and process surface EMG signals, amplify them analogically, and deliver proportional output to myoelectric prosthetic hand electronics with identical principles of operation, output specifications, power requirements, and frequency bandwidth. The contact material (AISI 316L steel) is the same approved material and has passed equivalent biocompatibility testing. The physical design difference (remote metallic plates versus integrated contacts) does not alter the fundamental function or safety profile.