510(k) · Cleared

Cleared

Neurotech Plus

K112258510(k) TraditionalCleared Jan 9, 2012157-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

Bio-Medical Research, Ltd. · GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief

Cleared on Jan 9, 2012 as substantially equivalent to K082011 (Bio-Medical Research, Ltd., 2008) and 2 other predicates after a 157-day review. Its family tree reaches back 2 generations to 2004.

Decided: Jan 9, 2012
Review: 157 days
Class: Class II
Product code: GZJ
Recalls: None
Predicates: 3

Its longest line of descent runs back 2 generations to K032003 (2004). 6 ancestors in all, the oldest K971437 (1997). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK032003 Premier PlusAmerican Imex · 2004
1 generation backK061516 Staodyn Max Preset, Model 4470Compex Technologies, Inc. · 2007
This deviceK112258 Neurotech PlusBio-Medical Research, Ltd. · 2012

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K032003	Premier Plus	American Imex	2004	—
−1	K061516	Staodyn Max Preset, Model 4470	Compex Technologies, Inc.	2007	—
0 (this device)	K112258	Neurotech Plus	Bio-Medical Research, Ltd.	2012	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1997	1	0
2002	2	0
2008	1	0

FIG. 1 — Lineage of K112258, 2004–2012Source: 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

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What was it cleared against? (3)

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
*	K082011	Medistim XP, Type 281 and Meditens XP, Type 458 Summary page 1 …roduct Code: OZJ, NYN, I PF Device Class: 11 3. Identification of Equivalent Legally Marketed Device 5 10(k) Number: K082011I Manufacturer: Rio-Medical Research Ltd. Trade Name: MediStim XP, Type 281…	Bio-Medical Research, Ltd.	2008	—
*	K061516	Staodyn Max Preset, Model 4470 Summary page 2 …K08201 1 Manufacturer: Bio-Medical Research Ltd. Trade Name: MediTens XP, Type 458 5 10(k) Number: K(061516 Manufacturer: Compex Technologies Trade Name: Staodyn® Max, Model 4470 5 10O(k) Number:…	Compex Technologies, Inc.	2007	—
*	K971437	Bionicare Stimulator System. Model Bio-1000	Murray Electronics	1997	—

Also cleared against K082011: 3 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 8 years and passes through 3 companies; a new generation was cleared every 4.9 years on median.
None of the 6 ancestors has a recall.
3 other devices also cite its predicate K082011.

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. 2012, 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 Neurotech Plus device is indicated for the following: In combination Neuromuscular Electrical Stimulation (NMES) and Transcutaneous Electrical Nerve Stimulation (TENS) modes, models 431, 432, 433, 434, 436, 439 & 440: NMES Indications: Maintain or increase the range of motion Prevention or retardation of disuse atrophy Re-educate muscles Relax muscle spasms Increase local blood circulation Prevention of venous thrombosis of the calf muscles…

Read the full statement (192 words)

The Neurotech Plus device is indicated for the following:

In combination Neuromuscular Electrical Stimulation (NMES) and Transcutaneous Electrical Nerve Stimulation (TENS) modes, models 431, 432, 433, 434, 436, 439 & 440:

NMES Indications:

Maintain or increase the range of motion

Prevention or retardation of disuse atrophy

Re-educate muscles

Relax muscle spasms

Increase local blood circulation

Prevention of venous thrombosis of the calf muscles immediately after surgery

TENS Indications:

Symptomatic relief and management of chronic, intractable pain

Relief of pain associated with arthritis

Adjunctive treatment in the management of post-surgical and post-trauma pain

Adjunctive therapy in reducing the level of pain and symptoms associated with osteoarthritis of the knee (models 431, 432 and 433 only)

In Neuromuscular Electrical Stimulation (NMES) only mode, models 437 & 441:

Maintain or increase the range of motion

Prevention or retardation of disuse atrophy

Re-educate muscles

Relax muscle spasms

Increase local blood circulation

Prevention of venous thrombosis of the calf muscles immediately after surgery

In Transcutaneous Electrical Nerve Stimulation (TENS) only mode, model 438:

Symptomatic relief and management of chronic, intractable pain

Relief of pain associated with arthritis

Adjunctive treatment in the management of post-surgical and post-trauma pain

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K112258 · printed Nov 6, 2026

Cite this page

510(k) Report. “K112258: Neurotech Plus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112258

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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