510(k) · Cleared

Cleared

Biotouch Massage Therapy System

K013061510(k) TraditionalCleared Jul 1, 2002293-day reviewClass II21 CFR 890.5650

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

Tactile Systems Technology, Inc. · IRP Massager, Powered Inflatable Tube

Cleared on Jul 1, 2002 as substantially equivalent to K914774 (Talley Group, Ltd., 1992) after a 293-day review. Its family tree reaches back 1 generation to 1992. 30 later devices descend from it.

Decided: Jul 1, 2002
Review: 293 days
Class: Class II
Product code: IRP
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K914774 (1992). 30 later devices descend from it, 5 citing it directly.

By dateBy generation

Root · 1 generation backK914774 Multipulse Sequential Compression UnitTalley Group, Ltd. · 1992
This deviceK013061 Biotouch Massage Therapy SystemTactile Systems Technology, Inc. · 2002
Descendant · cites it directly · 14 of its ownK080134 Compressible Limb and Circulation Therapy System, Model WHF-314…Wonjin Mulsan Co., Ltd. · 2009
Descendant · 2 generations on · 13 of its ownK100656 Compressible Limb Therapy System Model WHF-324 (Power-Q1000 Plus)Wonjin Mulsan Co., Ltd. · 2010
Descendant · cites it directly · 10 of its ownK062818 Flexitouch SystemTactile Systems Technology, Inc. · 2006
Descendant · cites it directly · 9 of its ownK120972 Flexitouch SystemTactile Systems Technology, Inc. · 2012
Descendant · cites it directly · 8 of its ownK153311 Flexitouch SystemTactile Systems Technology, Inc. (Dba Tactile Medical) · 2016

Showing 5 of 30 descendants. See all descendants

Descendants cleared per year

2006high 4 (2012) · low 0 (2007)2026

Most influential descendants

Showing 5 of 30 · See all

K080134Compressible Limb and Circulation Therapy System, Model WHF-314 (Power-Q1000)Wonjin Mulsan Co., Ltd. · 2009 · cites it directly14descendants
K100656Compressible Limb Therapy System Model WHF-324 (Power-Q1000 Plus)Wonjin Mulsan Co., Ltd. · 2010 · 2 generations on13descendants
K062818Flexitouch SystemTactile Systems Technology, Inc. · 2006 · cites it directly10descendants
K120972Flexitouch SystemTactile Systems Technology, Inc. · 2012 · cites it directly9descendants
K153311Flexitouch SystemTactile Systems Technology, Inc. (Dba Tactile Medical) · 2016 · cites it directly8descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K914774	Multipulse Sequential Compression Unit	Talley Group, Ltd.	1992	—
0 (this device)	K013061	Biotouch Massage Therapy System	Tactile Systems Technology, Inc.	2002	—
+1	K080134	Compressible Limb and Circulation Therapy System, Model WHF-314 (Power-Q1000)	Wonjin Mulsan Co., Ltd.	2009	—
+2	K100656	Compressible Limb Therapy System Model WHF-324 (Power-Q1000 Plus)	Wonjin Mulsan Co., Ltd.	2010	—
+1	K062818	Flexitouch System	Tactile Systems Technology, Inc.	2006	—
+1	K120972	Flexitouch System	Tactile Systems Technology, Inc.	2012	—
+1	K153311	Flexitouch System	Tactile Systems Technology, Inc. (Dba Tactile Medical)	2016	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2006	2	0
2009	1	0
2010	2	0
2011	2	0
2012	4	0
2013	1	0
2015	1	0
2016	1	0
2017	4	0
2019	1	0
2020	3	0
2021	3	0
2023	2	0
2024	1	0
2025	1	0
2026	1	0

FIG. 1 — Lineage of K013061, 1992–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 IRP? 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 IRP device

#1 K193354 Air Compression Therapy Devicescore 28.6 · 8 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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What was it cleared against? (1)

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.

Type	Number	Device	Applicant	Decided	Recalls
*	K914774	Multipulse Sequential Compression Unit Summary page 2 …s with respect to intended use, design, materials and construction: (Progressive Medical Technology, Inc., Multipuise Sequential Compression Unit (K914774)) No new safety andfor effectiveness issues are raised. 6. Summary of Studies Performance testing was completed to v…	Talley Group, Ltd.	1992	—

Also cleared against K914774: 2 other devices →

What descends from it? (30)

See all 30

5 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K080134	Compressible Limb and Circulation Therapy System, Model WHF-314 (Power-Q1000)	Wonjin Mulsan Co., Ltd.	2009	14
K062818	Flexitouch System	Tactile Systems Technology, Inc.	2006	10
K120972	Flexitouch System	Tactile Systems Technology, Inc.	2012	9
K153311	Flexitouch System	Tactile Systems Technology, Inc. (Dba Tactile Medical)	2016	8
K053225	Cellu M6 Keymodule I	Lpg One, Inc.	2006	3

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?

Its one ancestor has no recall.
Of its descendants, K080134 (Wonjin Mulsan Co., Ltd., 2009) has gone furthest, with 14 descendants of its own.
2 other devices also cite its predicate K914774.

How does its category compare?

All IRP devices

IRP Massager, Powered Inflatable Tube: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · IRP

13in 2025

2007high 19 (2021) · low 1 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · IRP

141in 2025

2007high 172 (2026) · low 80 (2018)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · IRP

2in 2017

2007high 2 (2017) · low 0 (2007)2026

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

Adverse event reports per year · IRP

10in 2025

2007high 10 (2025) · low 0 (2007)2025

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

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	2	—	0	0
2008	1	—	0	2
2009	1	—	0	1
2010	2	—	0	5
2011	3	164	1	3
2012	5	116	0	3
2013	2	—	0	0
2014	4	113	0	0
2015	2	—	0	3
2016	1	—	0	2
2017	4	170	2	0
2018	3	80	0	0
2019	10	83	0	0
2020	9	150	0	1
2021	19	140	0	0
2022	14	97	0	1
2023	10	143	0	0
2024	12	115	0	4
2025	13	141	0	10
2026	12	172	0	—

What is it indicated for?

The biofouchTMdevice is intended for use by medical professionals and patients at home, who are under medical supervision, in treating many conditions, such as:

Primary lymphedema

Post mastectomy edema

Edema following trauma and sport injuries

Post immobilization edema

Venous insufficiencies

Lymphedema.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K013061 · printed Nov 6, 2026

Cite this page

510(k) Report. “K013061: Biotouch Massage Therapy System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K013061

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026