510(k) Report

510(k) · Cleared

Cleared

Everelife Transcutaneous Muscle Stimulator

K071624510(k) TraditionalCleared Nov 27, 2007166-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

Everlife Medical Equipment Co., Ltd. · GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief

Cleared on Nov 27, 2007 as substantially equivalent to K902102 (Apex Medical, Inc., 1991) and 4 other predicates after a 166-day review. Its family tree reaches back 1 generation to 1991.

Decided
Nov 27, 2007
Review
166 days
Class
Class II
Product code
GZJ
Recalls
None
Predicates
5

Its longest line of descent runs back 1 generation to K902102 (1991). 5 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2002: 1 other ancestor2001: 1 other ancestor1997: 1 other ancestor1993: 1 other ancestorK902102 · Com-Tens: a Neurostimulator · Apex Medical, Inc. · 19911990199520002005
Other ancestors, by generation 1 generation back: 4 other ancestors K902102 · Com-Tens: a Neurostimulator · Apex Medical, Inc. · 19910
  1. Root · 1 generation backK902102 Com-Tens: a NeurostimulatorApex Medical, Inc. · 1991
  2. This deviceK071624 Everelife Transcutaneous Muscle StimulatorEverlife Medical Equipment Co., Ltd. · 2007
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K902102Com-Tens: a NeurostimulatorApex Medical, Inc.1991—
0 (this device)K071624Everelife Transcutaneous Muscle StimulatorEverlife Medical Equipment Co., Ltd.2007—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199310
199710
200110
200210
FIG. 1 — Lineage of K071624, 1991–2007Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K252767 actiTENS miniscore 13.1 · 9 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (5)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K902102Com-Tens: a Neurostimulator
Summary page 1
…anscutaneous Nerve Stimulator NAME: REGULATI ON NUMBER: 882.5890, GZJ, C lass II PREDICATED APEX Transcutaneous Nerve Stimulator, DEVICE: K902102, K931570, K012643, K021755, K970429, ( Please refer to the following comparison page.) INTENDED USE: To…
Apex Medical, Inc.1991—
*K931570Com-Tens (Single Mode)
Summary page 1
…ous Nerve Stimulator NAME: REGULATI ON NUMBER: 882.5890, GZJ, C lass II PREDICATED APEX Transcutaneous Nerve Stimulator, DEVICE: K902102, K931570, K012643, K021755, K970429, ( Please refer to the following comparison page.) INTENDED USE: To be used i…
Ems Dist.1993—
*K012643Apex Medical LCD Tens-Vii
Summary page 1
…Stimulator NAME: REGULATI ON NUMBER: 882.5890, GZJ, C lass II PREDICATED APEX Transcutaneous Nerve Stimulator, DEVICE: K902102, K931570, K012643, K021755, K970429, ( Please refer to the following comparison page.) INTENDED USE: To be used in symptom…
Apex Medical Corp.2001—
*K021755Apex Medical Digital Tens TS1211, TS1212
Summary page 1
…or NAME: REGULATI ON NUMBER: 882.5890, GZJ, C lass II PREDICATED APEX Transcutaneous Nerve Stimulator, DEVICE: K902102, K931570, K012643, K021755, K970429, ( Please refer to the following comparison page.) INTENDED USE: To be used in symptomatic reli…
Apex Medical Corp.2002—
*K970429Bioscope SD Tens, Arista SD Plus, AP-102080T
Summary page 1
…REGULATI ON NUMBER: 882.5890, GZJ, C lass II PREDICATED APEX Transcutaneous Nerve Stimulator, DEVICE: K902102, K931570, K012643, K021755, K970429, ( Please refer to the following comparison page.) INTENDED USE: To be used in symptomatic relief of chr…
Apex Medical Corp.1997—

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?

  • None of the 5 ancestors has a recall.

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

2007: 132008: 112009: 162010: 52011: 52012: 122013: 22014: 42015: 32016: 32017: 32018: 22019: 32020: 42021: 32022: 42023: 12024: 32025: 12026 (partial year): 2
2007high 16 (2009) · low 1 (2023)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GZJ

207in 2024

2007: 223 days median2008: 136 days median2009: 155 days median2010: 232 days median2011: 168 days median2012: 154 days median2014: 344 days median2015: 202 days median2016: 163 days median2017: 113 days median2019: 156 days median2020: 183 days median2021: 231 days median2022: 175 days median2024: 207 days median
2007high 344 (2014) · low 113 (2017)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · GZJ

1in 2011

2007: 42008: 12011: 1
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

2007: 42008: 452009: 172010: 222011: 222012: 202013: 102014: 232015: 182016: 322017: 582018: 212019: 72020: 102021: 52022: 42023: 392024: 122025: 13
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071322344
200811136145
200916155017
20105232022
20115168122
201212154020
20132—010
20144344023
20153202018
20163163032
20173113058
20182—021
2019315607
20204183010
2021323105
2022417504
20231—039
20243207012
20251—013
20262—0—

What is it indicated for?

To be used in symptomatic relief of chronic intractable pain, post-traumatic and post-surgical pain.

Indications for use as stated in the FDA summary.

More from Everlife Medical Equipment Co., Ltd.

3 FDA decisions under this applicant name. See the company

  • K071320Everlife Powered Muscle Stimulator, Model E-100204, E-100504, E-100509, E-100804, E-201111, E-201211, E-201311Everlife Medical Equipment Co., Ltd. · 2007
  • K070890Everlife Interferential Current Therapy, Model IF-100507Everlife Medical Equipment Co., Ltd. · 2007

Recent decisions in GZJ

The GZJ category page

  • K252712STIMPOD NMS460 Nerve StimulatorAlgiamed Technologies USA, Inc. · 2026
  • K252767actiTENS miniSublimed · 2026
  • K252236CP Relief Wand Rx - TENS/NMESN & C Holdings, LLC · 2025
  • K232441Unipro (K-UNIPRO-US)Tenscare, Ltd. · 2024
  • K241228TENSWaveZynex Medical Officer · 2024

https://510kreport.com/device/K071624 · printed Nov 5, 2026

Cite this page

510(k) Report. “K071624: Everelife Transcutaneous Muscle Stimulator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K071624

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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