# K250200: InbellaBody System

- Pathway: 510(k) (Special)
- Applicant: Inbella Medical, Inc.
- Decided: Feb 11, 2025 after 19 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 21 generations back to K943450 (1995). 108 ancestors in all.
No later device cites it as a predicate yet.
0 of 109 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K231495: The Evolve System with the Transform Applicator, InMode, Ltd. (2023) Summary page 6.

## Indications for use
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

Source page: https://510kreport.com/device/K250200
Methodology: https://510kreport.com/methodology