InbellaBody System

The InBellaBody System with BellaTform Applicator is a radiofrequency (RF) and electromuscular stimulation (EMS) / transcutaneous nerve stimulation (TENS) device designed for multiple medical applications. In RF mode, it provides temporary relief of minor muscle aches, pain, and muscle spasm while improving local blood circulation. In EMS mode, it relaxes muscle spasms, prevents muscle atrophy, increases blood circulation, and aids muscle re-education. In TENS mode, it manages chronic pain and post-surgical/post-trauma acute pain. In sequential RF/EMS mode, it performs non-invasive fat breakdown (lipolysis) and reduces abdominal circumference.

The InBellaBody System is physically and functionally identical to the predicate Evolve System with Transform Applicator (K231495), sharing the same RF energy delivery mechanism, EMS-TENS technology, software control architecture, and component specifications including LCD touchscreen, power supply (48V AC/DC), real-time controller, RF generators, and applicator design. The only difference is the manufacturer (Inbella Medical Inc. versus InMode Ltd.).

ANSI AAMI ES 60601-1:2005/(R)2012 with amendments (medical electrical equipment general safety), IEC 60601-1-6 Edition 3.1 2013-10 (usability), IEC 60601-1-2 Edition 4.0 2014-02 (electromagnetic disturbances), and IEC 60601-2-2 Edition 6.0 2017-03 (high frequency surgical equipment safety and performance).

Substantial equivalence is established through identical indications for use and technological characteristics between the InBellaBody System and the predicate Evolve System. Since the device is manufactured to the same specifications with identical functionality, design, and intended clinical applications as the already-cleared predicate, only differing in manufacturer identity, the device poses no new safety or efficacy concerns and therefore meets the legal standard for substantial equivalence.