510(k) · Cleared

Cleared

Relaxor Perfect Touch Air Massaging System

K030437510(k) TraditionalCleared Apr 10, 200359-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

Salton, Inc. · IRP Massager, Powered Inflatable Tube

Cleared on Apr 10, 2003 after a 59-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 59 later devices descend from it.

Decided: Apr 10, 2003
Review: 59 days
Class: Class II
Product code: IRP
Recalls: None
Predicates: 0

59 later devices descend from it, 7 citing it directly.

This deviceK030437 Relaxor Perfect Touch Air Massaging SystemSalton, Inc. · 2003
Descendant · cites it directly · 55 of its ownK071596 Potable Air Massager Putifino, Model AM-7Nihon Seimitsu Sokki Co., Ltd. · 2008
Descendant · cites it directly · 54 of its ownK092435 Verseo Air Pressure MassagerThe American Export Group & International Services · 2010
Descendant · cites it directly · 53 of its ownK122154 Powerplay Muscle MassagerFig, LLC · 2012
Descendant · 2 generations on · 51 of its ownK160608 NormaTec Pulse and NormaTec Pulse ProNormaTec Industries, LP · 2016
Descendant · cites it directly · 38 of its ownK182668 Rapid Reboot Compression Therapy SystemRapid Reboot Recovery Products, LLC · 2018

Showing 5 of 59 descendants. See all descendants

Descendants cleared per year

2008high 13 (2021) · low 0 (2009)2026

Most influential descendants

Showing 5 of 59 · See all

K071596Potable Air Massager Putifino, Model AM-7Nihon Seimitsu Sokki Co., Ltd. · 2008 · cites it directly55descendants
K092435Verseo Air Pressure MassagerThe American Export Group & International Services · 2010 · cites it directly54descendants
K122154Powerplay Muscle MassagerFig, LLC · 2012 · cites it directly53descendants
K160608NormaTec Pulse and NormaTec Pulse ProNormaTec Industries, LP · 2016 · 2 generations on51descendants
K182668Rapid Reboot Compression Therapy SystemRapid Reboot Recovery Products, LLC · 2018 · cites it directly38descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K030437	Relaxor Perfect Touch Air Massaging System	Salton, Inc.	2003	—
+1	K071596	Potable Air Massager Putifino, Model AM-7	Nihon Seimitsu Sokki Co., Ltd.	2008	—
+1	K092435	Verseo Air Pressure Massager	The American Export Group & International Services	2010	—
+1	K122154	Powerplay Muscle Massager	Fig, LLC	2012	—
+2	K160608	NormaTec Pulse and NormaTec Pulse Pro	NormaTec Industries, LP	2016	—
+1	K182668	Rapid Reboot Compression Therapy System	Rapid Reboot Recovery Products, LLC	2018	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2008	1	0
2010	1	0
2012	1	0
2013	1	0
2014	1	0
2016	1	0
2018	2	0
2019	2	0
2020	5	0
2021	13	0
2022	11	0
2023	3	0
2024	6	0
2025	6	0
2026	5	0

FIG. 1 — Lineage of K030437, 2003–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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

Get a 510(k) Report

What was it cleared against?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (59)

See all 59

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

Number	Device	Applicant	Decided	Descendants
K071596	Potable Air Massager Putifino, Model AM-7	Nihon Seimitsu Sokki Co., Ltd.	2008	55
K092435	Verseo Air Pressure Massager	The American Export Group & International Services	2010	54
K122154	Powerplay Muscle Massager	Fig, LLC	2012	53
K182668	Rapid Reboot Compression Therapy System	Rapid Reboot Recovery Products, LLC	2018	38
K193354	Air Compression Therapy Device	Shenzhen Dongjilian Electronics Co., Ltd.	2020	20
K123829	Portable Therapeutix Squid Active Cold Compression Device and Cold Pack	Portable Therapeutix, LLC	2013	2
K202693	NeoWave Pain Relief and Recovery System, Model# T16-2020	Eva Medtec, Inc.	2021	0

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?

Of its descendants, K071596 (Nihon Seimitsu Sokki Co., Ltd., 2008) has gone furthest, with 55 descendants of its own.

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 Perfect Touch™ Air Massaging System 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 Perfect Touch™ simulates kneading and stroking of tissues by using an inflatable garment.

Indications for use as stated in the FDA 510(k) statement.

https://510kreport.com/device/K030437 · printed Nov 6, 2026

Cite this page

510(k) Report. “K030437: Relaxor Perfect Touch Air Massaging System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K030437

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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