510(k) · Cleared

Cleared

Low Back Pain Relief System /Models GM310PP,GM320PP,GM321PP, and GM330PP

K060222510(k) TraditionalCleared Apr 28, 200688-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

Gemore Technology Co, Ltd. · NUH Stimulator, Nerve, Transcutaneous, Over-The-Counter

Cleared on Apr 28, 2006 as substantially equivalent to K040512 (Well-Life Healthcare, Inc., 2004) after an 88-day review. Its family tree reaches back 1 generation to 2004. 14 later devices descend from it.

Decided: Apr 28, 2006
Review: 88 days
Class: Class II
Product code: NUH
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K040512 (2004). 14 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 1 generation backK040512 Limited Function WL/Otc-Tens Device, Model WL-2103A, WL-2203A…Well-Life Healthcare, Inc. · 2004
This deviceK060222 Low Back Pain Relief System /Models GM310PP,GM320PP,GM321PP, and…Gemore Technology Co, Ltd. · 2006
Descendant · cites it directly · 11 of its ownK090042 Painmaster MCT PatchNewmark, Inc. · 2009
Descendant · 2 generations on · 5 of its ownK130114 Painmaster MCT PatchNewmark, Inc. · 2013
Descendant · 2 generations on · 4 of its ownK120500 The Pain Pilot (a.K.a Pain Pilot)Hollywog, LLC · 2012
Descendant · 3 generations on · 2 of its ownK152852 ALEVE Direct Therapy (ALEVE Direct Therapy TENS device)Bayer Healthcare, LLC · 2015
Descendant · 3 generations on · 1 of its ownK133789 Dolphin Neurostim OtcAcumed Medical, Ltd. · 2015

Showing 5 of 14 descendants. See all descendants

Descendants cleared per year

2009high 3 (2015) · low 0 (2010)2026

Most influential descendants

Showing 5 of 14 · See all

K090042Painmaster MCT PatchNewmark, Inc. · 2009 · cites it directly11descendants
K130114Painmaster MCT PatchNewmark, Inc. · 2013 · 2 generations on5descendants
K120500The Pain Pilot (a.K.a Pain Pilot)Hollywog, LLC · 2012 · 2 generations on4descendants
K152852ALEVE Direct Therapy (ALEVE Direct Therapy TENS device)Bayer Healthcare, LLC · 2015 · 3 generations on2descendants
K133789Dolphin Neurostim OtcAcumed Medical, Ltd. · 2015 · 3 generations on1descendant

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K040512	Limited Function WL/Otc-Tens Device, Model WL-2103A, WL-2203A, WL-2203B and…	Well-Life Healthcare, Inc.	2004	—
0 (this device)	K060222	Low Back Pain Relief System /Models GM310PP,GM320PP,GM321PP, and GM330PP	Gemore Technology Co, Ltd.	2006	—
+1	K090042	Painmaster MCT Patch	Newmark, Inc.	2009	—
+2	K130114	Painmaster MCT Patch	Newmark, Inc.	2013	—
+2	K120500	The Pain Pilot (a.K.a Pain Pilot)	Hollywog, LLC	2012	—
+3	K152852	ALEVE Direct Therapy (ALEVE Direct Therapy TENS device)	Bayer Healthcare, LLC	2015	—
+3	K133789	Dolphin Neurostim Otc	Acumed Medical, Ltd.	2015	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2009	1	0
2011	2	0
2012	1	0
2013	1	0
2014	1	0
2015	3	0
2016	1	0
2018	1	0
2019	3	0

FIG. 1 — Lineage of K060222, 2004–2019Source: 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 NUH? 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 NUH device

#1 K190783 Health Expert Electronic Stimulator (model…score 15.8 · 7 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? (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
*	K040512	Limited Function WL/Otc-Tens Device, Model WL-2103A, WL-2203A, WL-2203B and WL-2401 Summary page 1 …k Pain Relief System models GM31OPP, GM32OPP, GM321PP, and GM33OPP are of comparable type and are substantially equivalent to the following predicate devices: - K040512: Limit Function WL/OTC-TENS/Model WL-2403. 4. Device Description: The Gemore Low Back Pain Relief System, models GM31OPP, G…	Well-Life Healthcare, Inc.	2004	—

Also cleared against K040512: 3 other devices →

What descends from it? (14)

See all 14

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

Number	Device	Applicant	Decided	Descendants
K090042	Painmaster MCT Patch	Newmark, Inc.	2009	11
K110716	Everyway Low Back Pain Relief System	Everyway Medical Instruments Co.,Ltd	2011	0
K110390	Etg 255 Combo Stimualtor, Ten 260 Stimualtor	Handelshaus Dittman GmbH	2011	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, K090042 (Newmark, Inc., 2009) has gone furthest, with 11 descendants of its own.
3 other devices also cite its predicate K040512.

How does its category compare?

All NUH devices

NUH Stimulator, Nerve, Transcutaneous, Over-The-Counter: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · NUH

15in 2025

2007high 20 (2022) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NUH

119in 2025

2007high 231 (2011) · low 90 (2024)2026

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

Recalls per year · NUH

No recall names NUH since 2007.

Adverse event reports per year · NUH

7in 2025

2007high 21 (2017) · low 0 (2007)2025

MAUDE reports naming product code NUH, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	MAUDE reports
2007	4	161	0
2008	0	—	0
2009	1	—	0
2010	3	148	0
2011	6	231	0
2012	6	170	0
2013	10	189	1
2014	16	212	9
2015	14	198	11
2016	13	145	13
2017	17	155	21
2018	16	121	18
2019	19	213	5
2020	14	147	8
2021	14	198	7
2022	20	103	2
2023	15	127	4
2024	20	90	7
2025	15	119	7
2026	5	137	—

What is it indicated for?

The model GM31OPP, GM32OPP, GM321PP, and GM321PP are intended for temporary relief of pain associated with sore and aching muscles in the lower back due to strain from exercise or normal household and work activities.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K060222 · printed Nov 5, 2026

Cite this page

510(k) Report. “K060222: Low Back Pain Relief System /Models GM310PP,GM320PP,GM321PP, and GM330PP.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K060222

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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