510(k) Report

510(k) · Cleared

Cleared

Cellu M6 Keymodule I

K053225510(k) TraditionalCleared Nov 6, 2006354-day reviewClass I21 CFR 890.5660

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Lpg One, Inc. · ISA Massager, Therapeutic, Electric

Cleared on Nov 6, 2006 as substantially equivalent to K990445 (Lpg USA, Inc., 2000) and 5 other predicates after a 354-day review. Its family tree reaches back 2 generations to 1985. 3 later devices descend from it.

Decided
Nov 6, 2006
Review
354 days
Class
Class I
Product code
ISA
Recalls
None
Predicates
6

Its longest line of descent runs back 2 generations to K850851 (1985). 8 ancestors in all. 3 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2005: 1 other ancestor2002: 1 other ancestor1998: 1 other ancestor1992: 1 other ancestor1991: 2 other ancestors2010: 1 descendant cleared2013: 1 descendant cleared2017: 1 descendant clearedK850851 · G5 Apparatus T, K1, K3 & the President Model's · Physio Technology, Inc. · 1985K990445 · LPG Therapeutic Massager, Models -Esi, Therapeutic Massager/Vibrator · Lpg USA, Inc. · 20001990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 5 other ancestors2 generations back: 1 other ancestor 1 generation forward: 1 descendant2 generations forward: 1 descendant3 generations forward: 1 descendant K990445 · LPG Therapeutic Massager, Models -Esi, Therapeutic Massager/Vibrator · Lpg USA, Inc. · 2000K850851 · G5 Apparatus T, K1, K3 & the President Model's · Physio Technology, Inc. · 19850
  1. Root · 2 generations backK850851 G5 Apparatus T, K1, K3 & the President Model'sPhysio Technology, Inc. · 1985
  2. 1 generation backK990445 LPG Therapeutic Massager, Models -Esi, Therapeutic Massager/VibratorLpg USA, Inc. · 2000
  3. This deviceK053225 Cellu M6 Keymodule ILpg One, Inc. · 2006
  4. Descendant · cites it directly · 2 of its ownK092734 E-Light LineEspansione Marketing S.P.A · 2010
  5. Descendant · 2 generations on · 1 of its ownK124064 Young AgainEspansione Marketing S.P.A · 2013
  6. Descendant · 3 generations on · 0 of its ownK162556 Lightfusion Led SystemVitage Led, Ltd. · 2017

Most influential descendants

Showing 3 of 3 · See all
  • K092734E-Light LineEspansione Marketing S.P.A · 2010 · cites it directly2descendants
  • K124064Young AgainEspansione Marketing S.P.A · 2013 · 2 generations on1descendant
  • K162556Lightfusion Led SystemVitage Led, Ltd. · 2017 · 3 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K850851G5 Apparatus T, K1, K3 & the President Model'sPhysio Technology, Inc.1985—
−1K990445LPG Therapeutic Massager, Models -Esi, Therapeutic Massager/VibratorLpg USA, Inc.2000—
0 (this device)K053225Cellu M6 Keymodule ILpg One, Inc.2006—
+1K092734E-Light LineEspansione Marketing S.P.A2010—
+2K124064Young AgainEspansione Marketing S.P.A2013—
+3K162556Lightfusion Led SystemVitage Led, Ltd.2017—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199120
199210
199810
200210
200510

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201010
201310
201710
FIG. 1 — Lineage of K053225, 1985–2017Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in ISA? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new ISA device

  1. #1 K243488 Vmat Proscore 13.0 · 15 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (6)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K990445LPG Therapeutic Massager, Models -Esi, Therapeutic Massager/Vibrator
Summary page 1
…cation Name: Electrical Therapeutic Massager 10-Substantial Equivalency is claimed against the following devices: 1- LPG One (formerly LPG USA) ES1 Massager- 510k #K990445 2- Shepard Medical's Sport Pump- 510k #K912004 3- Progressive Medical's Multipulse Sequential Compression unit- 510k…
Lpg USA, Inc.2000—
*K912004Shepard Cryopress/Camp Multi-Temp Sport Pumps
Summary page 1
…antial Equivalency is claimed against the following devices: 1- LPG One (formerly LPG USA) ES1 Massager- 510k #K990445 2- Shepard Medical's Sport Pump- 510k #K912004 3- Progressive Medical's Multipulse Sequential Compression unit- 510k #K914774 4- Grad-Line's Atlant's- 510k…
Shepherd Medical Products, Inc.1991—
*K914774Multipulse Sequential Compression Unit
Summary page 1
…A) ES1 Massager- 510k #K990445 2- Shepard Medical's Sport Pump- 510k #K912004 3- Progressive Medical's Multipulse Sequential Compression unit- 510k #K914774 4- Grad-Line's Atlant's- 510k #K974395 5- Model SC-3008 Sequential Circulator- 510k #K043423 6- Flexitouch (als…
Talley Group, Ltd.1992—
*K974395Atlant's
Summary page 1
…rd Medical's Sport Pump- 510k #K912004 3- Progressive Medical's Multipulse Sequential Compression unit- 510k #K914774 4- Grad-Line's Atlant's- 510k #K974395 5- Model SC-3008 Sequential Circulator- 510k #K043423 6- Flexitouch (also known as Biotouch)- 510k #KO1 3061 11-Desc…
Grad-Line Corp.1998—
*K043423Model SC-3008 Sequential Circulator
Summary page 1
…Medical's Multipulse Sequential Compression unit- 510k #K914774 4- Grad-Line's Atlant's- 510k #K974395 5- Model SC-3008 Sequential Circulator- 510k #K043423 6- Flexitouch (also known as Biotouch)- 510k #KO1 3061 11-Description of the Device: The Cellu M6 Keymodule i electrical t…
Bio Compression Systems, Inc.2005—
*K013061Biotouch Massage Therapy SystemTactile Systems Technology, Inc.2002—

Also cleared against K990445: 6 other devices →

What descends from it? (3)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K092734E-Light LineEspansione Marketing S.P.A20102

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 21 years and passes through 3 companies; a new generation was cleared every 14.6 years on median.
  • None of the 8 ancestors has a recall.
  • Of its descendants, K092734 (Espansione Marketing S.P.A, 2010) has gone furthest, with 2 descendants of its own.
  • 6 other devices also cite its predicate K990445.

How does its category compare?

All ISA devices

ISA Massager, Therapeutic, Electric: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · ISA

1in 2025

2018: 22021: 12022: 22023: 22024: 12025: 1
2007high 2 (2018) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · ISA

Too few ISA 510(k)s in any year since 2007 to give a median.

Recalls per year · ISA

2in 2025

2008: 12011: 12025: 22026 (partial year): 1
2007high 2 (2025) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · ISA

16in 2025

2007: 22008: 102009: 32010: 12011: 32012: 22013: 52014: 62015: 62016: 122017: 62018: 22019: 62020: 62021: 32022: 82023: 142024: 132025: 16
2007high 16 (2025) · low 1 (2010)2025

MAUDE reports naming product code ISA, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—02
20080—110
20090—03
20100—01
20110—13
20120—02
20130—05
20140—06
20150—06
20160—012
20170—06
20182—02
20190—06
20200—06
20211—03
20222—08
20232—014
20241—013
20251—216
20260—1—

What is it indicated for?

Reduction of Secondary Lymphedema of the Arm (SLA) Post Mastectomy

Improvement of Secondary Lymphedema

Improvement of lymphatic circulation in the treated area

Indications for use as stated in the FDA summary.

Also cleared against K990445

6 other devices cite the same predicate.

  • K090221Reaction SystemViora, Ltd. · 2009
  • K090580Thermage Thermacool NXT System and AccessoriesSolta Medical, Inc. · 2009
  • K080300Cutera Multimodal Cellulite Product (Cmmcd)Cutera, Inc. · 2008
  • K061001ThermassageThermage, Inc. · 2006
  • K053611SmoothshapesBicellulase, Inc. · 2006
  • K050397Velasmooth, ShaperSyneron Medical, Ltd. · 2005

Recent decisions in ISA

The ISA category page

  • K243488Vmat ProTermosalud · 2025
  • K240358ShockPhysio Mobile (model SW3200 Basic)Shenzhen Dongdixin Technology Co., Ltd. · 2024
  • K221865BTL-094BTL Industries, Inc. · 2023
  • K210166Omnispec ED1000Medispec, Ltd. · 2023
  • K213120OW100S (model OW100S-US)Tissue Regeneration Technologies, LLC Dba AS Softwave Trt · 2022

https://510kreport.com/device/K053225 · printed Nov 6, 2026

Cite this page

510(k) Report. “K053225: Cellu M6 Keymodule I.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K053225

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026