510(k) · Cleared

Cleared

FD Tens 2090, FD Tens 2095

K152676510(k) TraditionalCleared Jan 22, 2016126-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 Jan 22, 2016 as substantially equivalent to K052813 (Fuji Dynamics Limited, 2006) and 1 other predicate after a 126-day review. Its family tree reaches back 2 generations to 2000.

Decided: Jan 22, 2016
Review: 126 days
Class: Class II
Product code: GZJ
Recalls: None
Predicates: 2

Its longest line of descent runs back 2 generations to K994266 (2000). 4 ancestors in all. 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 deviceK152676 FD Tens 2090, FD Tens 2095Fuji Dynamics, Ltd. · 2016

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)	K152676	FD Tens 2090, FD Tens 2095	Fuji Dynamics, Ltd.	2016	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2003	1	0
2007	1	0

FIG. 1 — Lineage of K152676, 2000–2016Source: 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? (2)

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 4 …GZJ, IPF Classification: Class II 3. Predicate Device Information 510k number Device Name Manufacturer Date cleared K052813 FD TENS 2030 Fuji Dynamics 2006 K063642 FD EMS…	Fuji Dynamics Limited	2006	—
*	K063642	FD Ems, Model # D-FJ30E Summary page 4 …Device Name Manufacturer Date cleared K052813 FD TENS 2030 Fuji Dynamics 2006 K063642 FD EMS Fuji Dynamics 2007 4. Device Description FD TENS 2090 FD TENS 2090…	Fuji Dynamics Limited	2007	—

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 16 years and passes through 2 companies; a new generation was cleared every 10.0 years on median.
None of the 4 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. 2016, 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?

As a TENS device, FD TENS 2090 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. As a EMS device, FD TENS 2090 is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes on the affected body area. It is intended for: • Prevention or…

Read the full statement (135 words)

As a TENS device, FD TENS 2090 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.

As a EMS device, FD TENS 2090 is an electrically powered device intended for medical purposes that repeatedly

contracts muscles by passing electrical currents through electrodes on the affected body area. It is intended for:

• Prevention or retardation of muscle disuse atrophy.

• Relaxation of muscle spasm.

• Muscle re-education.

• Maintaining or increasing range of motion.

• Increasing local blood circulation.

• Immediate post-surgical of calf muscle to prevent venous thrombosis.

FD TENS 2095 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 as stated in the FDA summary.

https://510kreport.com/device/K152676 · printed Nov 6, 2026

Cite this page

510(k) Report. “K152676: FD Tens 2090, FD Tens 2095.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K152676

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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