# K243164: INDIBA COMPACT devices

- Pathway: 510(k) (Traditional)
- Applicant: Indiba S. A. U.
- Decided: Nov 20, 2024 after 51 days
- Product code: PBX (Massager, Vacuum, Radio Frequency Induced Heat)
- 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: 3 generations back to K122389 (2012). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161458: Indiba Diathermia Radiofrequency Device - Activ; Indiba Diathermia Radiofrequency Device - Deep Care, Indiba USA, Inc. (2016) Summary page 5.

## Indications for use
INDIBA COMPACT devices are intended to provide topical heating for the purpose of elevating tissue temperature for treatment of selected medical conditions such as: relief of pain, muscle spasms and increase in local circulation. The massage electrodes are intended to provide a temporary reduction in the appearance of cellulite.

Source page: https://510kreport.com/device/K243164
Methodology: https://510kreport.com/methodology