510(k) · Cleared

Cleared

Smartwave MS 2000

K041063510(k) TraditionalCleared Dec 1, 2004222-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

Newwave Medical, LLC · IPF Stimulator, Muscle, Powered

Cleared on Dec 1, 2004 as substantially equivalent to K926510 (Staodyne, Inc., 1993) after a 222-day review. Its family tree reaches back 1 generation to 1993. 1 later device descends from it.

Decided: Dec 1, 2004
Review: 222 days
Class: Class II
Product code: IPF
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K926510 (1993). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK926510 Staodyn Ems+2Staodyne, Inc. · 1993
This deviceK041063 Smartwave MS 2000Newwave Medical, LLC · 2004
Descendant · cites it directly · 0 of its ownK121305 Sterling Medical Impulse 3 StimulatorArmstrong Industries, Inc. Dha Mediquip Int. Dha S · 2012

Most influential descendants

Showing 1 of 1 · See all

K121305Sterling Medical Impulse 3 StimulatorArmstrong Industries, Inc. Dha Mediquip Int. Dha S · 2012 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K926510	Staodyn Ems+2	Staodyne, Inc.	1993	—
0 (this device)	K041063	Smartwave MS 2000	Newwave Medical, LLC	2004	—
+1	K121305	Sterling Medical Impulse 3 Stimulator	Armstrong Industries, Inc. Dha Mediquip Int. Dha S	2012	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2012	1	0

FIG. 1 — Lineage of K041063, 1993–2012Source: 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? (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
*	K926510	Staodyn Ems+2 Summary page 2 …Marketed Device 1)510 (k) Number This Submission 2) Device Name K926510 Smartwave MS 2000 EMS i2 3) Manufacturer Neww…	Staodyne, Inc.	1993	—

Also cleared against K926510: 3 other devices →

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
K121305	Sterling Medical Impulse 3 Stimulator	Armstrong Industries, Inc. Dha Mediquip Int. Dha S	2012	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, K121305 (Armstrong Industries, Inc. Dha Mediquip Int. Dha S, 2012) has gone furthest, with 0 descendants of its own.
3 other devices also cite its predicate K926510.

How does its category compare?

All IPF devices

IPF Stimulator, Muscle, Powered: FDA decisions, review times, recalls and adverse event reports over 20 years.

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?

1. Relaxation of muscle spasms

2. Prevention or retardation of disuse atrophy

3. Increasing local blood circulation

4. Muscle re-education

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

6. Maintaining or increasing range of motion

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K041063 · printed Nov 4, 2026

Cite this page

510(k) Report. “K041063: Smartwave MS 2000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K041063

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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