# K210913: V12 PRO

- Pathway: 510(k) (Traditional)
- Applicant: Slk Medical GmbH
- Decided: Aug 4, 2021 after 128 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
Longest line of descent: 1 generation back to K150269 (2015). 1 ancestor in all.
1 later device descends 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)
- K150269: Ballancer 505 System, Model 1201-AC, Mego Afek AC, Ltd. (2015) Summary page 4.

## Most influential descendants
- K233238: Air Pressure Therapy System (Model:VU-IPC4M) (2024), 0 descendants of its own

## Indications for use
The V12 PRO is indicated for the temporary relief of minor muscle aches and pains and for temporary increase in circulation to the treated areas in people who are in good health. The V12 PRO simulates kneading and stroking of tissues by using an inflatable garment.

Source page: https://510kreport.com/device/K210913
Methodology: https://510kreport.com/methodology