510(k) · Cleared

Cleared

H-WAVE

K103738510(k) SpecialCleared Jun 1, 2011161-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

Electronic Waveform Laboratory, Inc. · IPF Stimulator, Muscle, Powered

Cleared on Jun 1, 2011 as substantially equivalent to K915230 (Electronic Waveform Laboratory, Inc., 1992) after a 161-day review. Its family tree reaches back 1 generation to 1992. 3 later devices descend from it.

Decided: Jun 1, 2011
Review: 161 days
Class: Class II
Product code: IPF
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K915230 (1992). 3 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backK915230 H Wave Muscle StimulatorElectronic Waveform Laboratory, Inc. · 1992
This deviceK103738 H-WAVEElectronic Waveform Laboratory, Inc. · 2011
Descendant · cites it directly · 2 of its ownK112485 H-WAVEElectronic Waveform Lab, Inc. · 2011
Descendant · 2 generations on · 1 of its ownK131910 MPPMarc Pro · 2014
Descendant · cites it directly · 0 of its ownK160255 HBOTC Muscle and Nerve StimulatorHb Medical, Inc. · 2016

Most influential descendants

Showing 3 of 3 · See all

K112485H-WAVEElectronic Waveform Lab, Inc. · 2011 · cites it directly2descendants
K131910MPPMarc Pro · 2014 · 2 generations on1descendant
K160255HBOTC Muscle and Nerve StimulatorHb Medical, Inc. · 2016 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K915230	H Wave Muscle Stimulator	Electronic Waveform Laboratory, Inc.	1992	—
0 (this device)	K103738	H-WAVE	Electronic Waveform Laboratory, Inc.	2011	—
+1	K112485	H-WAVE	Electronic Waveform Lab, Inc.	2011	—
+2	K131910	MPP	Marc Pro	2014	—
+1	K160255	HBOTC Muscle and Nerve Stimulator	Hb Medical, Inc.	2016	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2011	1	0
2014	1	0
2016	1	0

FIG. 1 — Lineage of K103738, 1992–2016Source: 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

Get a 510(k) Report

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
*	K915230	H Wave Muscle Stimulator Summary page 1 …ation Name Powered muscle stimulator 21 C.F.R. § 890.5850 (Product Code IPF) Predicate Devices H-Wave®(model P-4), Electronic Waveform Lab, Inc. (K91 5230) Device Description The H-Wave® model H4 is a portable battery operated electrical stimulation device with two channels, two se…	Electronic Waveform Laboratory, Inc.	1992	—

Also cleared against K915230: 1 other device →

What descends from it? (3)

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

Number	Device	Applicant	Decided	Descendants
K112485	H-WAVE	Electronic Waveform Lab, Inc.	2011	2
K160255	HBOTC Muscle and Nerve Stimulator	Hb Medical, Inc.	2016	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, K112485 (Electronic Waveform Lab, Inc., 2011) has gone furthest, with 2 descendants of its own.
1 other device also cites its predicate K915230.

How does its category compare?

All IPF devices

IPF Stimulator, Muscle, Powered: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 H-Wave® is indicated for the following conditions:

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; and

6. Maintaining or increasing range of motion.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K103738 · printed Nov 6, 2026

Cite this page

510(k) Report. “K103738: H-WAVE.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103738

Report an extraction error

Are you the manufacturer?

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