StarFormer (M008-3T)

StarFormer is a non-invasive therapeutic device using magnetic stimulation to treat pain and condition muscles. It comprises a system controller, high-voltage power supply, handheld magnetic coil applicators, and a chair-mounted applicator. In TENS mode, it stimulates peripheral nerves for relief of chronic, post-traumatic, and post-surgical pain in patients 18 years or older. In PMS (Pulsed Magnetic Stimulation) mode, it stimulates neuromuscular tissue for muscle conditioning and rehabilitation, including prevention of disuse atrophy.

StarFormer uses magnetic field stimulation (1.8 T ± 20%) with handheld and chair-back coil applicators, operating at 1–80 Hz repetition rate, 330 µs ± 10% pulse width, and biphasic sine waveform. It differs from predicate electrical TENS devices (which use electrode pads and direct electrical current) but operates on the same principle: generating electric impulses to stimulate nerves. The device has 4 output channels, touchscreen interface, and supports both continuous operation modes with individually adjustable treatment parameters.

IEC 60601-1:2020 (electrical safety, mechanical strength, thermal safety); IEC 60601-1-2:2020 (electromagnetic compatibility); FDA guidance on software verification and validation (2023); FDA cybersecurity guidance (2023); ISO 10993 (biocompatibility); ISO 13485 (quality management); IEC 62304 (medical device software lifecycle); ISO 14971 (risk management).

Although StarFormer uses magnetic stimulation whereas the Hi-Dow predicate uses electrical stimulation, both devices generate electric impulses to stimulate peripheral nerves and muscles. The submission argues that depending on location and intensity, both magnetic and electrical impulses achieve substantially the same clinical outcomes: nerve stimulation for pain relief or nerve-activated muscle contraction. Performance testing confirmed that technological differences (magnetic vs. electrical energy source, different pulse parameters) do not raise different safety or effectiveness questions. The device follows an established, well-characterized magnetic stimulation technology platform with no significant residual risk, supporting the SE determination without requiring clinical trials.