# K190015: Ballancer Gold, 1212

- Pathway: 510(k) (Traditional)
- Applicant: Mego Afek AC, Ltd.
- Decided: Mar 25, 2019 after 81 days
- Product code: IRP (Massager, Powered Inflatable Tube)
- Device class: 2
- Regulation: 21 CFR 890.5650
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
Ballancer® Gold is a pneumatic massage system intended to provide gradient pressure in areas to which the inflatable garment is applied. The Ballancer Gold is indicated for: • Simulate kneading and stroking of the tissues by use of an inflatable garment. • Temporary increase circulation in the areas which the garment is applied • Temporary relief of minor muscle aches and pains

Source page: https://510kreport.com/device/K190015
Methodology: https://510kreport.com/methodology