510(k) · Cleared

Cleared

Mediphysics Pain Treatment System, Model 1

K032928510(k) TraditionalCleared Dec 19, 200388-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

Mediphysics Pain Centers of America · GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief

Cleared on Dec 19, 2003 as substantially equivalent to K894127 (Lumiscope Co., Inc., 1989) and 5 other predicates after an 88-day review. Its family tree reaches back 2 generations to 1988. 2 later devices descend from it.

Decided: Dec 19, 2003
Review: 88 days
Class: Class II
Product code: GZJ
Recalls: None
Predicates: 6

Its longest line of descent runs back 2 generations to K881114 (1988). 10 ancestors in all. 2 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 2 generations backK881114 Empi Model 989, TensEmpi · 1988
1 generation backK970203 Epix VTEmpi · 1997
This deviceK032928 Mediphysics Pain Treatment System, Model 1Mediphysics Pain Centers of America · 2003
Descendant · cites it directly · 1 of its ownK070474 Newlife Sciences LLC, Model TMRNewlife Sciences, LLC · 2007
Descendant · 2 generations on · 0 of its ownK202186 TrueRelief DeviceTruerelief · 2021

Most influential descendants

Showing 2 of 2 · See all

K070474Newlife Sciences LLC, Model TMRNewlife Sciences, LLC · 2007 · cites it directly1descendant
K202186TrueRelief DeviceTruerelief · 2021 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K881114	Empi Model 989, Tens	Empi	1988	—
−1	K970203	Epix VT	Empi	1997	—
0 (this device)	K032928	Mediphysics Pain Treatment System, Model 1	Mediphysics Pain Centers of America	2003	—
+1	K070474	Newlife Sciences LLC, Model TMR	Newlife Sciences, LLC	2007	—
+2	K202186	TrueRelief Device	Truerelief	2021	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1989	2	0
1990	1	0
1996	1	0
1998	1	0
2001	1	0
2002	2	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2007	1	0
2021	1	0

FIG. 1 — Lineage of K032928, 1988–2021Source: 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 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? (6)

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
*	K894127	Lumiscope Model 1000/Apcc Model 1000 Summary page 1 …or the Treatment of Pain Classification Name: Class II; 21CFR 882.5890; Product Code GZJ 3. PREDICATE DEVICES * Therapeutic Devices Inc. TENS (K894127) * Empi Epix VT TENS (K970203) * Electro-Acuscope 85 (K88391 1) * Medical Devices Matrix I…	Lumiscope Co., Inc.	1989	—
*	K970203	Epix VT Summary page 1 …ion Name: Class II; 21CFR 882.5890; Product Code GZJ 3. PREDICATE DEVICES * Therapeutic Devices Inc. TENS (K894127) * Empi Epix VT TENS (K970203) * Electro-Acuscope 85 (K88391 1) * Medical Devices Matrix I TENS model 4700s (K895473) *…	Empi	1997	—
*	K883911	Electro-Acuscope 85 Summary page 1 …ct Code GZJ 3. PREDICATE DEVICES * Therapeutic Devices Inc. TENS (K894127) * Empi Epix VT TENS (K970203) * Electro-Acuscope 85 (K88391 1) * Medical Devices Matrix I TENS model 4700s (K895473) * Well Life Health Care Mini TENS WL-2403 (K0200…	Biomedical Design Instruments	1990	—
*	K895473	DSX (TM), Digital SX, Quantum DSX, Model 4700S Summary page 1 …ces Inc. TENS (K894127) * Empi Epix VT TENS (K970203) * Electro-Acuscope 85 (K88391 1) * Medical Devices Matrix I TENS model 4700s (K895473) * Well Life Health Care Mini TENS WL-2403 (K020020) * CEFAR Primo (K020803) 4. DEVICE DESCRIPTION…	Medical Devices, Inc.	1989	—
*	K020020	The Izzzy-Tens (WL-2401), the Slim-Tens (WL-2402), the Mens-Tens (WL2403), the Compact… Summary page 1 …* Electro-Acuscope 85 (K88391 1) * Medical Devices Matrix I TENS model 4700s (K895473) * Well Life Health Care Mini TENS WL-2403 (K020020) * CEFAR Primo (K020803) 4. DEVICE DESCRIPTION The MediPhysics Pain Treatment System, Model 1, consists o…	Well-Life Healthcare, Inc.	2002	—
*	K020803	Cefar Medical AB Cefar Primo Summary page 1 …K88391 1) * Medical Devices Matrix I TENS model 4700s (K895473) * Well Life Health Care Mini TENS WL-2403 (K020020) * CEFAR Primo (K020803) 4. DEVICE DESCRIPTION The MediPhysics Pain Treatment System, Model 1, consists of a control console, two Treatm…	Cefar Medical AB	2002	—

Also cleared against K894127: 1 other device →

What descends from it? (2)

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

Number	Device	Applicant	Decided	Descendants
K070474	Newlife Sciences LLC, Model TMR	Newlife Sciences, LLC	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?

The line of descent spans 15 years and passes through 2 companies; a new generation was cleared every 9.0 years on median.
None of the 10 ancestors has a recall.
Of its descendants, K070474 (Newlife Sciences, LLC, 2007) has gone furthest, with 1 descendant of its own.
1 other device also cites its predicate K894127.

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?

The MediPhysics Pain Treatment System, Model 1, is intended for temporary symptomatic relief of chronic intractable pain, and as an adjunctive treatment in the management of post-surgical and post-traumatic acute pain.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K032928 · printed Nov 4, 2026

Cite this page

510(k) Report. “K032928: Mediphysics Pain Treatment System, Model 1.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K032928

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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