510(k) · Cleared

Cleared

Home Microcurrent HMC

K935132510(k) TraditionalCleared Mar 14, 1994137-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

Medical Devices, Inc. · GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief

Cleared on Mar 14, 1994 after a 137-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 10 later devices descend from it.

Decided: Mar 14, 1994
Review: 137 days
Class: Class II
Product code: GZJ
Recalls: None
Predicates: 0

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

This deviceK935132 Home Microcurrent HMCMedical Devices, Inc. · 1994
Descendant · cites it directly · 5 of its ownK022405 Modification to Promax-XP, Tens and Microcurrent Device…Rehabilicare, Inc. · 2002
Descendant · 2 generations on · 3 of its ownK081835 Acticare IC and TseBioinduction Limited · 2009
Descendant · cites it directly · 3 of its ownK030998 Medrelief SE Series, Models SE-50, SE-100, SE-200, SE-300Healthonics, Inc. · 2003
Descendant · 3 generations on · 2 of its ownK161091 STIMPOD NMS460 Nerve StimulatorXavant Technology (Pty), Ltd. · 2017
Descendant · 2 generations on · 2 of its ownK060669 Medrelief ST Series, Models RT-50, ST-100, ST 150, ST-200, ST-300Healthonics, Inc. · 2006

Showing 5 of 10 descendants. See all descendants

Descendants cleared per year

2002high 3 (2007) · low 0 (2004)2026

Most influential descendants

Showing 5 of 10 · See all

K022405Modification to Promax-XP, Tens and Microcurrent Device; Promax-Tens, Tens Device…Rehabilicare, Inc. · 2002 · cites it directly5descendants
K081835Acticare IC and TseBioinduction Limited · 2009 · 2 generations on3descendants
K030998Medrelief SE Series, Models SE-50, SE-100, SE-200, SE-300Healthonics, Inc. · 2003 · cites it directly3descendants
K161091STIMPOD NMS460 Nerve StimulatorXavant Technology (Pty), Ltd. · 2017 · 3 generations on2descendants
K060669Medrelief ST Series, Models RT-50, ST-100, ST 150, ST-200, ST-300Healthonics, Inc. · 2006 · 2 generations on2descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K935132	Home Microcurrent HMC	Medical Devices, Inc.	1994	—
+1	K022405	Modification to Promax-XP, Tens and Microcurrent Device; Promax-Tens, Tens…	Rehabilicare, Inc.	2002	—
+2	K081835	Acticare IC and Tse	Bioinduction Limited	2009	—
+1	K030998	Medrelief SE Series, Models SE-50, SE-100, SE-200, SE-300	Healthonics, Inc.	2003	—
+3	K161091	STIMPOD NMS460 Nerve Stimulator	Xavant Technology (Pty), Ltd.	2017	—
+2	K060669	Medrelief ST Series, Models RT-50, ST-100, ST 150, ST-200, ST-300	Healthonics, Inc.	2006	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2002	1	0
2003	1	0
2006	1	0
2007	3	0
2009	1	0
2017	1	0
2022	1	0
2026	1	0

FIG. 1 — Lineage of K935132, 1994–2026Source: 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

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What was it cleared against?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (10)

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

Number	Device	Applicant	Decided	Descendants
K022405	Modification to Promax-XP, Tens and Microcurrent Device; Promax-Tens, Tens Device…	Rehabilicare, Inc.	2002	5
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, K022405 (Rehabilicare, Inc., 2002) has gone furthest, with 5 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/K935132 · printed Nov 6, 2026

Cite this page

510(k) Report. “K935132: Home Microcurrent HMC.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K935132

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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