BTL-199

The BTL-199 is an electromagnetic stimulator that delivers focused electromagnetic pulses to noninvasively stimulate peripheral nerves for pain relief. It is intended for relief of chronic intractable pain, post-traumatic pain, post-surgical pain, and chronic painful diabetic peripheral neuropathy in the lower extremities, for patients 18 and older. The device features a color touch-screen console with preset and customizable therapy parameters (frequency up to 150 Hz, therapy time up to 30 minutes, intensity 0-100%) and three interchangeable applicators for different body areas.

The BTL-199 uses single circular coils versus the K233364 predicate's figure-of-eight coil, though both generate electromagnetic fields to depolarize nerve axons. It supports pulse frequencies up to 150 Hz compared to K233364's 2 Hz maximum, similar to K230014's 100 Hz. Maximum output power is 100% at up to 14 Hz (versus K233364's 2 Hz), with peak magnetic field up to 2.0 T. The device includes a temperature sensor, intensity predictor function, and therapy discomfort button for safety. It has a modern touch-screen interface rather than LED displays on predicates.

IEC 60601-1 (medical electrical equipment general safety), IEC 60601-1-2 (electromagnetic compatibility), IEC 62304 (software life cycle), ISO 14971 (risk management), ISO 10993-1, 10993-5, and 10993-10 (biological evaluation and biocompatibility testing).

The BTL-199 shares the same intended use and peripheral nerve stimulation mechanism as both predicates. Although the BTL-199 supports higher pulse frequencies (150 Hz vs. 2 Hz for K233364), it allows physicians to set the identical cleared therapeutic protocol from K233364 (0.5 Hz frequency, 800 s duration, 400 pulses) via preset settings, demonstrating comparable effectiveness at the therapeutic frequency. The higher maximum frequency option does not create new safety risks because the device is prescription-only, limiting parameters to physician discretion, and includes built-in safeguards (temperature monitoring, intensity predictor, discomfort button). The circular-coil design difference from K233364's butterfly coil is negligible in practice; both K230014 and K233364 employ different coil geometries without affecting safety or efficacy. Maximum output power of 100% at up to 14 Hz exceeds K233364 but matches K230014 and is equivalent at the therapeutic 0.5 Hz frequency where both achieve 100% over 800 s.