510(k) · Cleared

Cleared

Veinoplus Neuromuscular Stimulator

K072252510(k) TraditionalCleared Jan 30, 2008170-day reviewClass II21 CFR 890.5850

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

Ad Rem Technology Sarl · IPF Stimulator, Muscle, Powered

Cleared on Jan 30, 2008 as substantially equivalent to K022175 (Valmed Corp., 2002) after a 170-day review. Its family tree reaches back 1 generation to 2002. 1 later device descends from it.

Decided: Jan 30, 2008
Review: 170 days
Class: Class II
Product code: IPF
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K022175 (2002). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK022175 P4 PhysioValmed Corp. · 2002
This deviceK072252 Veinoplus Neuromuscular StimulatorAd Rem Technology Sarl · 2008
Descendant · cites it directly · 0 of its ownK141919 Veinoplus Sport Neuromuscular StimulatorAd Rem Technology Sarl · 2015

Most influential descendants

Showing 1 of 1 · See all

K141919Veinoplus Sport Neuromuscular StimulatorAd Rem Technology Sarl · 2015 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K022175	P4 Physio	Valmed Corp.	2002	—
0 (this device)	K072252	Veinoplus Neuromuscular Stimulator	Ad Rem Technology Sarl	2008	—
+1	K141919	Veinoplus Sport Neuromuscular Stimulator	Ad Rem Technology Sarl	2015	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2015	1	0

FIG. 1 — Lineage of K072252, 2002–2015Source: 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 IPF? 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 IPF device

#1 K241433 EVE Synergy (EVE-20M)score 19.7 · 25 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? (2)

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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.

Type	Number	Device	Applicant	Decided	Recalls
*	K022175	P4 Physio Summary page 2 …activated, the Indications for Use are: - Providing symptomatic pain relief for chronic, acute or post operative pain. 4-0 PREDICATE DEVICES K022175 Trade/Device Name: VALMED P4-PHYSIO. Regulation Number: 21 CFR 890.5850…	Valmed Corp.	2002	—
Kept off the family tree	K040253	FDA’s K040253 is Easy Med TN-28 C Our reading of the summary gave K040253, FDA’s number for Easy Med TN-28 C (Easy Med Instrument Co., Ltd.). Its FDA name has none of the distinctive words the summary uses for the device it names, “EASYMED TN-28C T.E.N.S. Unit”. Kept off the family tree. Summary page 3 …cle Stimulator Regulatory Class: Class II Product Code: IPF The equivalence is claimed only for the Operational Mode number 1 of the VEINOPLUS® K040253 Trade/Device Name: EASYMED TN-28C T.E.N.S. Unit Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous elec…	Easy Med Instrument Co., Ltd.	2004	—

Also cleared against K022175: 1 other device →

What descends from it? (1)

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

Number	Device	Applicant	Decided	Descendants
K141919	Veinoplus Sport Neuromuscular Stimulator	Ad Rem Technology Sarl	2015	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?

Its one ancestor has no recall.
Of its descendants, K141919 (Ad Rem Technology Sarl, 2015) has gone furthest, with 0 descendants of its own.
1 other device also cites its predicate K022175.

How does its category compare?

All IPF devices

IPF Stimulator, Muscle, Powered: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.

FDA decisions per year · IPF

3in 2025

2007high 15 (2021) · low 3 (2015)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · IPF

257in 2025

2007high 275 (2011) · low 43 (2015)2026

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

Recalls per year · IPF

1in 2023

2007high 3 (2012) · low 0 (2007)2026

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

Adverse event reports per year · IPF

8in 2025

2007high 213 (2008) · low 2 (2017)2025

MAUDE reports naming product code IPF, 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	8	143	0	11
2008	6	140	1	213
2009	7	216	0	150
2010	4	121	0	14
2011	4	275	1	25
2012	4	269	3	16
2013	10	180	0	6
2014	4	264	0	19
2015	3	43	0	11
2016	7	113	0	8
2017	5	110	0	2
2018	5	73	0	3
2019	4	133	0	10
2020	9	121	0	13
2021	15	98	0	3
2022	7	108	0	4
2023	9	255	1	8
2024	7	201	0	5
2025	3	257	0	8
2026	3	206	0	—

What is it indicated for?

The VEINOPLUS Neuromuscular Stimulator is indicated for the following: In the Primary Mode of Action (PMOA) when the Operating Mode number 1 for muscle stimulation is activated, the Indications for Use are: * Relaxation of muscle spasms. * Prevention or retardation of muscle disuse atrophy. • Increasing local blood circulation. • Muscle re-education. • Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis * Maintaining or…

Read the full statement (109 words)

The VEINOPLUS Neuromuscular Stimulator is indicated for the following:

In the Primary Mode of Action (PMOA) when the Operating Mode number 1 for muscle stimulation is activated, the Indications for Use are:

* Relaxation of muscle spasms.

* Prevention or retardation of muscle disuse atrophy.

• Increasing local blood circulation.

• Muscle re-education.

• Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis

* Maintaining or increasing range of motion.

In the other Mode of Action (MOA), when the Operating Mode number 2 for Transcutaneous Electrical Nerve Stimulation (TENS) stimulation is activated, the Indication for Use is:

Providing symptomatic pain relief for chronic, acute or post operative pain.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K072252 · printed Nov 6, 2026

Cite this page

510(k) Report. “K072252: Veinoplus Neuromuscular Stimulator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K072252

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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