# K122112: 2004-OC Massage System, 2008-OC Massage System

- Pathway: 510(k) (Traditional)
- Applicant: Bio Compression Systems, Inc.
- Decided: Apr 9, 2013 after 266 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 K112479 (2011). 1 ancestor in all.
2 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112479: DSJ Massager, Mego Afek AC, Ltd. (2011) Summary page 1.

## Most influential descendants
- K213533: Sequential Circulators SC-1004-DL, SC-1008-DL, SC-2004-DL, SC-2008-DL, SC-4004-DL, SC-4008-DL (2022), 0 descendants of its own
- K201645: Massage Compression Boots (2020), 0 descendants of its own

## Indications for use
The 2004-00 and 2008-0C Massage Systems are powered inflatable tube massagers intended to temporarily relieve minor muscle aches and/or pains, and to temporarily increase circulation to the treated areas. The devices are intended for home use by people who are in good health.

Source page: https://510kreport.com/device/K122112
Methodology: https://510kreport.com/methodology
