510(k) · Cleared

Cleared

Bio-Stim Kit

K050174510(k) TraditionalCleared Sep 7, 2005225-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

Skylark Device & Systems Co., Ltd. · GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief

Cleared on Sep 7, 2005 after a 225-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 154 later devices descend from it.

Decided: Sep 7, 2005
Review: 225 days
Class: Class II
Product code: GZJ
Recalls: None
Predicates: 0

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

This deviceK050174 Bio-Stim KitSkylark Device & Systems Co., Ltd. · 2005
Descendant · cites it directly · 151 of its ownK060846 Therapeutic Massage CompanionEndurance Therapeutics · 2007
Descendant · 2 generations on · 78 of its ownK102598 HI-Dow-XPHi-Dow International, Inc. · 2011
Descendant · 2 generations on · 58 of its ownK112392 Hivox Biotek Inc.Hivox Biotek, Inc. · 2012
Descendant · 2 generations on · 55 of its ownK122744 Prospera Otc Tens Electronic Pulse MassagerProspera Corporation · 2013
Descendant · 2 generations on · 50 of its ownK110068 Model PM3030Omron Healthcare, Inc. · 2011

Showing 5 of 154 descendants. See all descendants

Descendants cleared per year

2007high 15 (2014) · low 0 (2008)2026

Most influential descendants

Showing 5 of 154 · See all

K060846Therapeutic Massage CompanionEndurance Therapeutics · 2007 · cites it directly151descendants
K102598HI-Dow-XPHi-Dow International, Inc. · 2011 · 2 generations on78descendants
K112392Hivox Biotek Inc.Hivox Biotek, Inc. · 2012 · 2 generations on58descendants
K122744Prospera Otc Tens Electronic Pulse MassagerProspera Corporation · 2013 · 2 generations on55descendants
K110068Model PM3030Omron Healthcare, Inc. · 2011 · 2 generations on50descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K050174	Bio-Stim Kit	Skylark Device & Systems Co., Ltd.	2005	—
+1	K060846	Therapeutic Massage Companion	Endurance Therapeutics	2007	—
+2	K102598	HI-Dow-XP	Hi-Dow International, Inc.	2011	—
+2	K112392	Hivox Biotek Inc.	Hivox Biotek, Inc.	2012	—
+2	K122744	Prospera Otc Tens Electronic Pulse Massager	Prospera Corporation	2013	—
+2	K110068	Model PM3030	Omron Healthcare, Inc.	2011	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2007	2	0
2010	4	0
2011	3	0
2012	5	0
2013	8	0
2014	15	0
2015	9	0
2016	6	0
2017	15	0
2018	8	0
2019	14	0
2020	11	0
2021	13	0
2022	11	0
2023	9	0
2024	7	0
2025	9	0
2026	5	0

FIG. 1 — Lineage of K050174, 2005–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), 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’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (154)

See all 154

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

Number	Device	Applicant	Decided	Descendants
K060846	Therapeutic Massage Companion	Endurance Therapeutics	2007	151
K063743	Rhythm Touch Q 2-Way	Shockim Enterprises, Ltd.	2007	1

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, K060846 (Endurance Therapeutics, 2007) has gone furthest, with 151 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	—

What is it indicated for?

This BIO-STIM KIT is intended for temporary relief of pain associated with sore and aching muscle in the lower back due to strain from exercise or normal household and work activities.

Indications for use as stated in the FDA 510(k) statement.

https://510kreport.com/device/K050174 · printed Nov 5, 2026

Cite this page

510(k) Report. “K050174: Bio-Stim Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K050174

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