# K230385: Ballancer Platinum (1222)

- Pathway: 510(k) (Traditional)
- Applicant: Mego Afek
- Decided: Apr 4, 2023 after 49 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
The Ballancer® Platinum is a pneumatic massage system intended to provide gradient pressure in areas, which the inflatable garment is applied. The Ballancer® Platinum System 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/K230385
Methodology: https://510kreport.com/methodology