510(k) · Cleared

Cleared

Apex Medical Digital Tens TS1211, TS1212

K021755510(k) SpecialCleared Jun 12, 200214-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

Apex Medical Corp. · GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief

Cleared on Jun 12, 2002 after a 14-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 25 later devices descend from it.

Decided: Jun 12, 2002
Review: 14 days
Class: Class II
Product code: GZJ
Recalls: None
Predicates: 0

25 later devices descend from it, 6 citing it directly.

This deviceK021755 Apex Medical Digital Tens TS1211, TS1212Apex Medical Corp. · 2002
Descendant · cites it directly · 14 of its ownK060246 InfrexJohari Digital Healthcare, Ltd. · 2006
Descendant · 2 generations on · 11 of its ownK072123 Homewave Neuromodulations Pain Therapy DeviceBiowave Corporation · 2008
Descendant · 3 generations on · 9 of its ownK161154 Smartpatch PNS MicroLead and Accessories, Smartpatch PNS Stimulator…Spr Therapeutics, LLC · 2016
Descendant · 4 generations on · 7 of its ownK170902 Sprint System, Single Procedure Kit, Sprint System with Pad II…Spr Therapeutics, LLC · 2017
Descendant · 5 generations on · 6 of its ownK181422 SPRINT Peripheral Nerve Stimulation System, Extensa, SPRINT…Spr Therapeutics, Inc. · 2018

Showing 5 of 25 descendants. See all descendants

Descendants cleared per year

2004high 5 (2008) · low 0 (2005)2026

Most influential descendants

Showing 5 of 25 · See all

K060246InfrexJohari Digital Healthcare, Ltd. · 2006 · cites it directly14descendants
K072123Homewave Neuromodulations Pain Therapy DeviceBiowave Corporation · 2008 · 2 generations on11descendants
K161154Smartpatch PNS MicroLead and Accessories, Smartpatch PNS Stimulator, Pads, and…Spr Therapeutics, LLC · 2016 · 3 generations on9descendants
K170902Sprint System, Single Procedure Kit, Sprint System with Pad II, Single Procedure Kit…Spr Therapeutics, LLC · 2017 · 4 generations on7descendants
K181422SPRINT Peripheral Nerve Stimulation System, Extensa, SPRINT Peripheral Nerve Stimulation…Spr Therapeutics, Inc. · 2018 · 5 generations on6descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K021755	Apex Medical Digital Tens TS1211, TS1212	Apex Medical Corp.	2002	—
+1	K060246	Infrex	Johari Digital Healthcare, Ltd.	2006	—
+2	K072123	Homewave Neuromodulations Pain Therapy Device	Biowave Corporation	2008	—
+3	K161154	Smartpatch PNS MicroLead and Accessories, Smartpatch PNS Stimulator, Pads, and…	Spr Therapeutics, LLC	2016	—
+4	K170902	Sprint System, Single Procedure Kit, Sprint System with Pad II, Single…	Spr Therapeutics, LLC	2017	—
+5	K181422	SPRINT Peripheral Nerve Stimulation System, Extensa, SPRINT Peripheral Nerve…	Spr Therapeutics, Inc.	2018	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2004	1	0
2006	1	0
2007	2	0
2008	5	0
2009	2	0
2010	1	0
2011	1	0
2015	1	0
2016	2	0
2017	1	0
2018	1	0
2021	3	0
2022	2	0
2023	1	0
2025	1	0

FIG. 1 — Lineage of K021755, 2002–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (25)

See all 25

6 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K060246	Infrex	Johari Digital Healthcare, Ltd.	2006	14
K081141	Combocare 2000	Xanacare Technologies, LLC	2008	6
K071869	Tens/IF 14	Emsi	2008	0
K071624	Everelife Transcutaneous Muscle Stimulator	Everlife Medical Equipment Co., Ltd.	2007	0
K061828	Lorenz Biotech Aptiva, Version 2.13	Lorenz Biotech S.P.A.	2007	0
K041172	Basba E-Machine	Basba, Inc.	2004	0

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?

Of its descendants, K060246 (Johari Digital Healthcare, Ltd., 2006) has gone furthest, with 14 descendants of its own.

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?

Apex Medical Digital TENS is intended to be used in symptomatic relief of chronic intractable pain, post-traumatic and post-surgical pain.

Indications for use as stated in the FDA 510(k) statement.

https://510kreport.com/device/K021755 · printed Nov 6, 2026

Cite this page

510(k) Report. “K021755: Apex Medical Digital Tens TS1211, TS1212.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K021755

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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