CoolTone

The CoolTone is a non-invasive therapeutic device that produces an electromagnetic field to stimulate muscles. It is intended for improvement of abdominal tone and strengthening of abdominal muscles, as well as strengthening, toning, and firming of buttocks and thighs through muscle stimulation.

The device has identical technological characteristics to its predicate (K220601): Class I electrical protection (BF type), 12-inch touch screen interface, magnetic field intensity of 0.5–1.35T (±20%), two synchronous output channels, symmetrical biphasic sine wave stimulation at 1–150 Hz with 370 µs (±20%) pulse duration, up to 30 minutes treatment time, and 80 kg weight. Both devices use firmware-controlled voltage regulation with automatic shutoff.

The submission references compliance with 60601 (medical device electrical safety standard), 21 CFR 898 (general controls for muscle stimulators), and FDA guidance documents for powered muscle stimulators from June 1999. Voluntary standards compliance is confirmed but specific standard numbers are not detailed in this summary.

The subject device is substantially equivalent because it has no changes in indications for use (same as K220601), identical technological characteristics across all measured parameters (frequency, pulse width, magnetic field intensity, output channels, waveform, and physical specifications), and labeling changes that do not affect intended use, performance, or risk profile. The device maintains the same principle of action (nerve action potential initiation resulting in muscle contraction) and safety mechanisms as the predicate device.