510(k) · Cleared
ClearedTenscare Itouch Model (S) Easy and Plus
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tenscare, Ltd. · GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief
Cleared on Feb 9, 2009 as substantially equivalent to K040253 (Easy Med Instrument Co., Ltd., 2004) and 1 other predicate after a 175-day review. Its family tree reaches back 2 generations to 2002.
- Decided
- Feb 9, 2009
- Review
- 175 days
- Class
- Class II
- Product code
- GZJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K021359 (2002). 5 ancestors in all, the oldest K994266 (2000). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K021359 | Digi-Pro Tens Model WL-2203 and WL-2205 | Well-Life Healthcare, Inc. | 2002 | — |
| −1 | K032720 | Gem-Stim Tens, Models GM3XY and GM3AXY | Gemore Technology Co, Ltd. | 2003 | — |
| 0 (this device) | K082377 | Tenscare Itouch Model (S) Easy and Plus | Tenscare, Ltd. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
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
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 | Decided |
|---|---|---|---|
| * | K040253 | Easy Med TN-28 CSummary page 2…Nerve, Transcutaneous, for Pain Relief - GZJ; 21 CFR 882.5890. Device Classification: Class II Predicate Devices: EasyMed TENS Unit TN-28C (K040253) Gemore GM300T (K032720) (http://www.gemore.com.tw/) The class of the predicate Devices:… | 2004 |
| * | K032720 | Gem-Stim Tens, Models GM3XY and GM3AXYSummary page 2…21 CFR 882.5890. Device Classification: Class II Predicate Devices: EasyMed TENS Unit TN-28C (K040253) Gemore GM300T (K032720) (http://www.gemore.com.tw/) The class of the predicate Devices: Class II Device Description: A porta… | 2003 |
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 7 years and passes through 3 companies; a new generation was cleared every 5.2 years on median.
- None of the 5 ancestors has a recall.
- 3 other devices also cite its predicate K040253.
How does its category compare?
All GZJ devicesGZJ Stimulator, Nerve, Transcutaneous, For Pain Relief: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · GZJ
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GZJ
207in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GZJ
1in 2011
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GZJ
13in 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?
TENS stands for Transcutaneous Electrical Nerve Stimulation.
This TENS system is indicated for:
* Symptomatic relief and management of chronic, intractable pain.
* Adjunctive treatment for post-surgical and post-trauma acute pain.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082377 · printed Nov 4, 2026
Cite this page
510(k) Report. “K082377: Tenscare Itouch Model (S) Easy and Plus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K082377
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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