# K150269: Ballancer 505 System, Model 1201-AC

- Pathway: 510(k) (Traditional)
- Applicant: Mego Afek AC, Ltd.
- Decided: May 26, 2015 after 111 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.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices 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.

## Most influential descendants
- K210913: V12 PRO (2021), 1 descendant of its own
- K233238: Air Pressure Therapy System (Model:VU-IPC4M) (2024), 0 descendants of its own

## Indications for use
Ballancer 505 is a pneumatic massage system intended to provide gradient pressure in areas, which the inflatable garment is applied. The Ballancer 505 System is indicated for: * Simulating kneading and stroking of the tissues by use of an inflatable garment * Temporary increase circulation in areas which the garment is applied * Temporary relief of minor muscle aches and pains

Source page: https://510kreport.com/device/K150269
Methodology: https://510kreport.com/methodology