# K053225: Cellu M6 Keymodule I

- Pathway: 510(k) (Traditional)
- Applicant: Lpg One, Inc.
- Decided: Nov 6, 2006 after 354 days
- Product code: ISA (Massager, Therapeutic, Electric)
- Device class: 1
- Regulation: 21 CFR 890.5660
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K850851 (1985). 8 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K990445: LPG Therapeutic Massager, Models -Esi, Therapeutic Massager/Vibrator, Lpg USA, Inc. (2000) Summary page 1.
- K912004: Shepard Cryopress/Camp Multi-Temp Sport Pumps, Shepherd Medical Products, Inc. (1991) Summary page 1.
- K914774: Multipulse Sequential Compression Unit, Talley Group, Ltd. (1992) Summary page 1.
- K974395: Atlant's, Grad-Line Corp. (1998) Summary page 1.
- K043423: Model SC-3008 Sequential Circulator, Bio Compression Systems, Inc. (2005) Summary page 1.
- K013061: Biotouch Massage Therapy System, Tactile Systems Technology, Inc. (2002)

## Most influential descendants
- K092734: E-Light Line (2010), 2 descendants of its own
- K124064: Young Again (2013), 1 descendant of its own
- K162556: Lightfusion Led System (2017), 0 descendants of its own

## Indications for use
Reduction of Secondary Lymphedema of the Arm (SLA) Post Mastectomy Improvement of Secondary Lymphedema Improvement of lymphatic circulation in the treated area

Source page: https://510kreport.com/device/K053225
Methodology: https://510kreport.com/methodology