510(k) · Cleared

Cleared

Lorenz Biotech Aptiva, Version 2.13

K061828510(k) TraditionalCleared Aug 24, 2007422-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

Lorenz Biotech S.P.A. · GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief

Cleared on Aug 24, 2007 as substantially equivalent to K021755 (Apex Medical Corp., 2002) and 8 other predicates after a 422-day review. Its family tree reaches back 2 generations to 1989.

Decided: Aug 24, 2007
Review: 422 days
Class: Class II
Product code: GZJ
Recalls: None
Predicates: 9

Its longest line of descent runs back 2 generations to K892649 (1989). 22 ancestors in all, the oldest K843924 (1985). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK892649 Verimed Myoexorciser Iii (Myo Iii)Verimed Holdings, Inc. · 1989
1 generation backK972487 Emg RetrainerChattanooga Group, Inc. · 1997
This deviceK061828 Lorenz Biotech Aptiva, Version 2.13Lorenz Biotech S.P.A. · 2007

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K892649	Verimed Myoexorciser Iii (Myo Iii)	Verimed Holdings, Inc.	1989	—
−1	K972487	Emg Retrainer	Chattanooga Group, Inc.	1997	—
0 (this device)	K061828	Lorenz Biotech Aptiva, Version 2.13	Lorenz Biotech S.P.A.	2007	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1985	1	0
1987	1	0
1991	1	0
1992	1	0
1993	2	0
1994	2	0
1995	1	0
1997	2	0
1998	2	0
1999	1	0
2001	3	0
2002	2	0
2003	1	0

FIG. 1 — Lineage of K061828, 1989–2007Source: 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? (9)

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
*	K021755	Apex Medical Digital Tens TS1211, TS1212 Summary page 1 …EDICATE DEVICES Functionality Predicate Device TENS * Apex Medical Digital TENS (K021755) * GEMS-HV TENS (K032994) * Bioscope…	Apex Medical Corp.	2002	—
*	K032994	GM3 Series HV Tens, Model GM3X3HV (Where X IS Parameter of Different Housing) Summary page 1 …Predicate Device TENS * Apex Medical Digital TENS (K021755) * GEMS-HV TENS (K032994) * Bioscope SD TENS (K970249) * Proma…	Gemore Technology Co, Ltd.	2003	—
*	K970429	Bioscope SD Tens, Arista SD Plus, AP-102080T Our reading of the summary gave K970249, FDA’s number for Simplex Airbrator (Simplex Medical Systems, Inc.). Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “Bioscope SD TENS”.	Apex Medical Corp.	1997	—
*	K022405	Modification to Promax-XP, Tens and Microcurrent Device; Promax-Tens, Tens Device… Summary page 1 …* GEMS-HV TENS (K032994) * Bioscope SD TENS (K970249) * Promax TENS (K022405) * NeuroTrain III (K003433) Electromyography (EMG)/Biofeedback a EMG Ret…	Rehabilicare, Inc.	2002	—
*	K003433	Neuro-Train Iii (3) Summary page 1 …* Bioscope SD TENS (K970249) * Promax TENS (K022405) * NeuroTrain III (K003433) Electromyography (EMG)/Biofeedback a EMG Retrainer Dual Channel (K972487)…	Sterne Equipment Co., Ltd.	2001	—
*	K972487	Emg Retrainer Summary page 1 …romax TENS (K022405) * NeuroTrain III (K003433) Electromyography (EMG)/Biofeedback a EMG Retrainer Dual Channel (K972487) a MES-9000/EMG System (K013399) a Sy…	Chattanooga Group, Inc.	1997	—
*	K013399	Model Mes-9000/Emg System Summary page 1 …n III (K003433) Electromyography (EMG)/Biofeedback a EMG Retrainer Dual Channel (K972487) a MES-9000/EMG System (K013399) a Synergy System (K981405) Nerve conduction velocity (ENG) Brevio (K0…	Myotronics-Noromed, Inc.	2001	—
*	K981405	Synergy LT Summary page 1 …iner Dual Channel (K972487) a MES-9000/EMG System (K013399) a Synergy System (K981405) Nerve conduction velocity (ENG) Brevio (K010269) Lorenz Biotech, S.p.A. August 6, 2007…	Oxford Instruments, Plc.	1998	—
*	K012069	Modification to:Brevio Nerve Conduction Test Instrument Our reading of the summary gave K010269, which is not a number in FDA’s lists. Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “Brevio”.	Neurotron Medical, Inc.	2001	—

Also cleared against K021755: 5 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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 18 years and passes through 3 companies; a new generation was cleared every 9.9 years on median.
None of the 22 ancestors has a recall.
5 other devices also cite its predicate K021755.

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. 2007, this device’s year, is highlighted.

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 Aptiva TM v2.13U is a multifunctional transcutaneous electrical nerve stimulator

(TENS) equipped with a surface electromyography and electroneurography.

Aptiva TM is indicated for symptomatic relief and management of chronic pain, intractable

pain and/or as an adjunctive treatment for the management of post-traumatic pain.

The dynamic surface electromyography and electroneurography system is used for

biofeedback, relaxation training, and muscle re-education as well as monitoring and

display of bioelectric signals produced by muscles, stimulate peripheral nerves, and

monitor and display the electrical activity produced by nerves.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K061828 · printed Nov 4, 2026

Cite this page

510(k) Report. “K061828: Lorenz Biotech Aptiva, Version 2.13.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K061828

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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