510(k) · Cleared

Cleared

Medrelief

K003507510(k) TraditionalCleared Feb 21, 2001100-day reviewClass II21 CFR 882.5890

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

Healthonics, Inc. · GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief

Cleared on Feb 21, 2001 after a 100-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 18 later devices descend from it.

Decided: Feb 21, 2001
Review: 100 days
Class: Class II
Product code: GZJ
Recalls: None
Predicates: 0

18 later devices descend from it, 2 citing it directly.

This deviceK003507 MedreliefHealthonics, Inc. · 2001
Descendant · cites it directly · 13 of its ownK013167 MODEL7500 Microcurrent Tens Device, MCT-F5, MCT-F50, MCT-F500Newcare Products, LLC · 2002
Descendant · 2 generations on · 11 of its ownK090042 Painmaster MCT PatchNewmark, Inc. · 2009
Descendant · 3 generations on · 5 of its ownK130114 Painmaster MCT PatchNewmark, Inc. · 2013
Descendant · 3 generations on · 4 of its ownK120500 The Pain Pilot (a.K.a Pain Pilot)Hollywog, LLC · 2012
Descendant · cites it directly · 3 of its ownK030998 Medrelief SE Series, Models SE-50, SE-100, SE-200, SE-300Healthonics, Inc. · 2003

Showing 5 of 18 descendants. See all descendants

Descendants cleared per year

2002high 3 (2015) · low 0 (2004)2026

Most influential descendants

Showing 5 of 18 · See all

K013167MODEL7500 Microcurrent Tens Device, MCT-F5, MCT-F50, MCT-F500Newcare Products, LLC · 2002 · cites it directly13descendants
K090042Painmaster MCT PatchNewmark, Inc. · 2009 · 2 generations on11descendants
K130114Painmaster MCT PatchNewmark, Inc. · 2013 · 3 generations on5descendants
K120500The Pain Pilot (a.K.a Pain Pilot)Hollywog, LLC · 2012 · 3 generations on4descendants
K030998Medrelief SE Series, Models SE-50, SE-100, SE-200, SE-300Healthonics, Inc. · 2003 · cites it directly3descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K003507	Medrelief	Healthonics, Inc.	2001	—
+1	K013167	MODEL7500 Microcurrent Tens Device, MCT-F5, MCT-F50, MCT-F500	Newcare Products, LLC	2002	—
+2	K090042	Painmaster MCT Patch	Newmark, Inc.	2009	—
+3	K130114	Painmaster MCT Patch	Newmark, Inc.	2013	—
+3	K120500	The Pain Pilot (a.K.a Pain Pilot)	Hollywog, LLC	2012	—
+1	K030998	Medrelief SE Series, Models SE-50, SE-100, SE-200, SE-300	Healthonics, Inc.	2003	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2002	1	0
2003	1	0
2006	1	0
2007	2	0
2009	1	0
2012	1	0
2013	1	0
2014	1	0
2015	3	0
2016	1	0
2018	1	0
2019	3	0
2022	1	0

FIG. 1 — Lineage of K003507, 2001–2022Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in GZJ? 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 GZJ device

#1 K252767 actiTENS miniscore 13.1 · 9 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 has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (18)

See all 18

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

Number	Device	Applicant	Decided	Descendants
K013167	MODEL7500 Microcurrent Tens Device, MCT-F5, MCT-F50, MCT-F500	Newcare Products, LLC	2002	13
K030998	Medrelief SE Series, Models SE-50, SE-100, SE-200, SE-300	Healthonics, Inc.	2003	3

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, K013167 (Newcare Products, LLC, 2002) has gone furthest, with 13 descendants of its own.

How does its category compare?

All GZJ devices

GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GZJ

1in 2025

2007high 16 (2009) · low 1 (2023)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GZJ

207in 2024

2007high 344 (2014) · low 113 (2017)2026

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

Recalls per year · GZJ

1in 2011

2007high 4 (2007) · low 0 (2009)2026

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

Adverse event reports per year · GZJ

13in 2025

2007high 58 (2017) · low 4 (2007)2025

MAUDE reports naming product code GZJ, 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	13	223	4	4
2008	11	136	1	45
2009	16	155	0	17
2010	5	232	0	22
2011	5	168	1	22
2012	12	154	0	20
2013	2	—	0	10
2014	4	344	0	23
2015	3	202	0	18
2016	3	163	0	32
2017	3	113	0	58
2018	2	—	0	21
2019	3	156	0	7
2020	4	183	0	10
2021	3	231	0	5
2022	4	175	0	4
2023	1	—	0	39
2024	3	207	0	12
2025	1	—	0	13
2026	2	—	0	—

https://510kreport.com/device/K003507 · printed Nov 6, 2026

Cite this page

510(k) Report. “K003507: Medrelief.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K003507

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Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026