510(k) · Cleared

Cleared

Medrelief SE Series, Models SE-50, SE-100, SE-200, SE-300

K030998510(k) TraditionalCleared Oct 10, 2003193-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

Healthonics, Inc. · IPF Stimulator, Muscle, Powered

Cleared on Oct 10, 2003 as substantially equivalent to K980040 (Nisha Communication Industries, 1998) and 3 other predicates after a 193-day review. Its family tree reaches back 1 generation to 1992. 3 later devices descend from it.

Decided: Oct 10, 2003
Review: 193 days
Class: Class II
Product code: IPF
Recalls: None
Predicates: 4

Its longest line of descent runs back 1 generation to K923914 (1992). 4 ancestors in all. 3 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK923914 IF-II (TM), Model 7200Medical Devices, Inc. · 1992
This deviceK030998 Medrelief SE Series, Models SE-50, SE-100, SE-200, SE-300Healthonics, Inc. · 2003
Descendant · cites it directly · 2 of its ownK060669 Medrelief ST Series, Models RT-50, ST-100, ST 150, ST-200, ST-300Healthonics, Inc. · 2006
Descendant · 2 generations on · 0 of its ownK062616 Wellnesspro 2010Intelsource Group, Inc. · 2007
Descendant · 2 generations on · 0 of its ownK062325 RS-4I Muscle Stimulator FamilyRs Medical · 2007

Most influential descendants

Showing 3 of 3 · See all

K060669Medrelief ST Series, Models RT-50, ST-100, ST 150, ST-200, ST-300Healthonics, Inc. · 2006 · cites it directly2descendants
K062616Wellnesspro 2010Intelsource Group, Inc. · 2007 · 2 generations on0descendants
K062325RS-4I Muscle Stimulator FamilyRs Medical · 2007 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K923914	IF-II (TM), Model 7200	Medical Devices, Inc.	1992	—
0 (this device)	K030998	Medrelief SE Series, Models SE-50, SE-100, SE-200, SE-300	Healthonics, Inc.	2003	—
+1	K060669	Medrelief ST Series, Models RT-50, ST-100, ST 150, ST-200, ST-300	Healthonics, Inc.	2006	—
+2	K062616	Wellnesspro 2010	Intelsource Group, Inc.	2007	—
+2	K062325	RS-4I Muscle Stimulator Family	Rs Medical	2007	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1994	1	0
1998	1	0
2001	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2006	1	0
2007	2	0

FIG. 1 — Lineage of K030998, 1992–2007Source: 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 19.6 · 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? (4)

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
*	K980040	Electronic Muscle Stimulator - Microstim J-1304D Summary page 1 …Microstim J-l304D, made by Nisha Communications Industries, Light Industrial Area, Jodhpur 342003 India, which was cleare,d for marketing by the FDA on July 13, 1998 as K980040; (2) in interferential stimulation functions to the I F 4 Model 7200, made by Medical Devices, Inc., 833 Third Street Southwest,…	Nisha Communication Industries	1998	—
*	K923914	IF-II (TM), Model 7200 Summary page 1 …e I F 4 Model 7200, made by Medical Devices, Inc., 833 Third Street Southwest, St. Paul, MN 55112-3483, which was cleared for marketing by the FDA on November 6, 1992 as K923914; and, (3) in microcurrent TENS stimulation functions to the original MedRelief device, made by Healthonics, Inc., 903 Main Street…	Medical Devices, Inc.	1992	—
*	K003507	Medrelief Summary page 1 …to the original MedRelief device, made by Healthonics, Inc., 903 Main Street South, New Ellenton, SC 29803, which was cleared for marketing by the FDA on Feb. 21,2001 as K003507, and to the Home Microcurrent HMC, also made by Medical Devices, Inc., which was cleared for marketing by the FDA on March 14, 19…	Healthonics, Inc.	2001	—
*	K935132	Home Microcurrent HMC Summary page 1 …the FDA on Feb. 21,2001 as K003507, and to the Home Microcurrent HMC, also made by Medical Devices, Inc., which was cleared for marketing by the FDA on March 14, 1994 as K935132. 000062 B. DEVICE DESCRIPTION. The M…	Medical Devices, Inc.	1994	—

What descends from it? (3)

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

Number	Device	Applicant	Decided	Descendants
K060669	Medrelief ST Series, Models RT-50, ST-100, ST 150, ST-200, ST-300	Healthonics, Inc.	2006	2

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?

None of the 4 ancestors has a recall.
Of its descendants, K060669 (Healthonics, Inc., 2006) has gone furthest, with 2 descendants of its own.

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?

The MedRelief SE-50 and SE-100, and the MedRelief SE-200 and SE-300 in subthreshold and interferential modes, are intended for the following indications: Relief of chronic intractable pain. Adjunctive treatment of post-surgical or post-traumatic acute pain. The MedRelief SE-200 and SE-300 in muscle stimulation mode are intended for the following indications: Relaxation of muscle spasms. Prevention or retardation of disuse atrophy. Muscle re-education.…

Read the full statement (136 words)

The MedRelief SE-50 and SE-100, and the MedRelief SE-200 and SE-300 in subthreshold and interferential modes, are intended for the following indications:

Relief of chronic intractable pain.

Adjunctive treatment of post-surgical or post-traumatic acute pain.

The MedRelief SE-200 and SE-300 in muscle stimulation mode are intended for the following indications:

Relaxation of muscle spasms.

Prevention or retardation of disuse atrophy.

Muscle re-education.

Increasing local blood circulation.

Maintaining or increasing range of motion

Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis (SE-300 only).

For the SE-200 and SE-300 in muscle stimulation mode, the lowest three intensity settings may not provide effective muscle contractions to achieve the indications for use, especially when applied to large muscles or muscle groups. These settings are provided so that the intensity may be ramped up slowly for improved user comfort.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K030998 · printed Nov 6, 2026

Cite this page

510(k) Report. “K030998: Medrelief SE Series, Models SE-50, SE-100, SE-200, SE-300.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K030998

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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