InbellaBody System

The InBellaBody System with BellaTform Applicator employs RF technology and EMS-TENS technology for the treatment of selected medical conditions. The BellaTform Applicator in RF mode is intended for the temporary relief of minor muscle aches and pain, temporary relief of muscle spasm, and temporary improvement of local blood circulation. The BellaTform Applicator in EMS mode is intended for:
• Relaxation of muscle spasms
• Prevention or retardation of disuse atrophy
• Increasing local blood circulation
• Muscle re-education
• Maintaining or increasing range of motion
• Immediate postsurgical stimulation of calf muscles to prevent venous thrombosis
The BellaTform Applicator in TENS mode is intended for:
• Symptomatic relief and management of chronic, intractable pain
• Post-surgical acute pain
• Post-trauma acute pain
Additionally the BellaTform Applicator in sequential RF/EMS mode is intended for:
• Non-invasive lipolysis (breakdown of fat) of the abdomen.
• Reduction in circumference of the abdomen

The InBellaBody System with BellaTform Applicator employs RF technology and EMS-TENS technology for the treatment of selected medical conditions. The BellaTform Applicator in RF mode is intended for the temporary relief of minor muscle aches and pain, temporary relief of muscle spasm, and temporary improvement of local blood circulation. The BellaTform Applicator in EMS mode is intended for: • Relaxation of muscle spasms • Prevention or retardation of disuse atrophy • Increasing local blood circulation • Muscle re-education • Maintaining or increasing range of motion • Immediate postsurgical stimulation of calf muscles to prevent venous thrombosis. The BellaTform Applicator in TENS mode is intended for: • Symptomatic relief and management of chronic, intractable pain • Post-surgical acute pain • Post-trauma acute pain. Additionally, the BellaTform Applicator in sequential RF/EMS mode is intended for: • Non-invasive lipolysis (breakdown of fat) of the abdomen. • Reduction in circumference of the abdomen.

The InBellaBody System with BellaTform Applicator is designed to deliver non-thermal RF energy and electro-muscle and transcutaneous nerve stimulation for the treatment of different body areas for various medical applications. The InBellaBody System software controls and regulate the different applied energies in accordance with the user system preprograming and treatment settings. The InBellaBody System includes the following components: • LCD display touch screen, • Audio loudspeaker, • 48V AC/DC power supply, • Real time controller, distributor card and 2 RF generators, • Fans. The System operates while connected to the BellaTform Applicator. Performance Standards: The InBellaBody System with BellaTform Applicator has been tested and complies with the following voluntary recognized standards: - ANSI AAMI ES 60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 (Consolidated Text) Medical electrical equipment - Part 1: General requirements for basic safety and essential performance. - IEC 60601-1-6 Edition 3.1 2013-10 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability - IEC 60601-1-2 Edition 4.0 2014-02 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests. - IEC 60601-2-2 Edition 6.0 2017-03 Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories.