510(k) · Cleared

Cleared

FD Tens 2070

K111654510(k) TraditionalCleared Mar 1, 2012262-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

Fuji Dynamics, Ltd. · GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief

Cleared on Mar 1, 2012 as substantially equivalent to K052813 (Fuji Dynamics Limited, 2006) after a 262-day review. Its family tree reaches back 2 generations to 2000.

Decided: Mar 1, 2012
Review: 262 days
Class: Class II
Product code: GZJ
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K994266 (2000). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK994266 Fdtens 2010Fuji Dynamics Limited · 2000
1 generation backK052813 FD Tens 2030, Model DFJ24TFuji Dynamics Limited · 2006
This deviceK111654 FD Tens 2070Fuji Dynamics, Ltd. · 2012

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K994266	Fdtens 2010	Fuji Dynamics Limited	2000	—
−1	K052813	FD Tens 2030, Model DFJ24T	Fuji Dynamics Limited	2006	—
0 (this device)	K111654	FD Tens 2070	Fuji Dynamics, Ltd.	2012	—

FIG. 1 — Lineage of K111654, 2000–2012Source: 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? (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
*	K052813	FD Tens 2030, Model DFJ24T Summary page 3 …different. E-2/7 E. 510(k) Summary (per 21 CFR 807.92) Characteristic FD2070 / Mini TENS FDTENS 2030 K052813 (Predicate Deviee) K111654 Waveform Symmetrical Bi-Phasic __Asymmetrical Bi-Phasic Shape Rectangular Rectangular Maximum Voltage…	Fuji Dynamics Limited	2006	—

Also cleared against K052813: 1 other device →

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 12 years and passes through 2 companies; a new generation was cleared every 6.1 years on median.
None of the 2 ancestors has a recall.
1 other device also cites its predicate K052813.

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?

FD207o is used for the symptomatic relief and management of chronic intractable pain and/or as an adjunctive treatment in the management of Post-surgical and Post-traumatic acute 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/K111654 · printed Nov 6, 2026

Cite this page

510(k) Report. “K111654: FD Tens 2070.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111654

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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