CoolTone

CoolTone is a non-invasive, mobile electromagnetic muscle stimulation device used to strengthen, tone, and firm the abdomen, buttocks, and thighs. It generates a magnetic field via applicators to induce muscle contractions for muscle training and may be used under medical supervision for adjunctive therapy, muscle spasm relaxation, and rehabilitative purposes.

CoolTone uses electromagnetic stimulation with a 0.5–1.35 T magnetic field at 370 µs pulse duration, operates continuously at 1–150 Hz with symmetrical biphasic sine waves, and features two non-contact applicators with a securement system. It differs from the BTL-899MS predicate in electrical protection class (Class I vs. Class II) and has slightly lower maximum magnetic field intensity compensated by longer pulse width.

IEC 60601-1 (electrical safety), IEC 60601-1-2 (electromagnetic compatibility), IEC TS 60601-4-2 (electromagnetic immunity), IEC 62304 (software life cycle), and ISO 14971 (risk management).

CoolTone has identical product codes (NGX, IPF), primary function, principle of action, and clinical use as the predicate BTL-899MS. Technological differences in magnetic field intensity, pulse duration, and electrical protection do not raise different safety or effectiveness questions because the device's effectiveness is maintained through compensating parameters, falls within typical clinical ranges of FDA-cleared comparable devices, and has passed applicable safety standards testing.