BTL-398

The BTL-398 is a non-invasive therapeutic device that delivers magnetic pulses to stimulate pelvic floor muscles for treating urinary incontinence in adults. It consists of a main unit with electromagnetic field generators and a microprocessor-controlled touch-screen interface, plus a chair applicator with an adjustable magnetic coil. Therapy is administered through clothing and can last up to 30 minutes.

The BTL-398 adds two new features compared to the predicate HPM-6000UF: (1) Dynamic HIFEM Technology (DHT) enabling horizontal coil position adjustment of ±100mm, and (2) Pressure Wave Technology (PWT) using air circulation through the seat cushion at 0-100% intensity and up to 40 Hz repetition rate. Both devices share identical magnetic field intensity (0.7–2.5 T), pulse parameters (280 µs, dual-phase sine pulses, 1–150 Hz), therapy modes, and operating specifications.

IEC 60601-1:2020 (Medical electrical equipment—Basic safety and essential performance); IEC 60601-1-2:2020 (Electromagnetic compatibility requirements and tests); FDA Guidance (2023) on Content of Premarket Submissions for Device Software Functions. Performance bench testing included magnetic field strength, coil surface temperature, and PWT feature validation.

Both devices target the same indication (male and female urinary incontinence), employ identical therapeutic principles (initiating nerve action potentials to cause muscle contraction), use the same magnetic field specifications and therapy modes, and are prescription-use chair-based systems for professional healthcare settings. The DTH and PWT features are ancillary positioning and comfort enhancements that do not alter the fundamental electromagnetic stimulation mechanism or safety profile. Performance testing confirmed the subject device met all acceptance criteria, demonstrating that the technological differences do not raise new safety or effectiveness questions.