510(k) · Cleared
ClearedClassic Tens
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Care Rehab, Inc. · GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief
Cleared on Mar 15, 2002 as substantially equivalent to K895473 (Medical Devices, Inc., 1989) after a 35-day review. Its family tree reaches back 1 generation to 1989. 3 later devices descend from it.
- Decided
- Mar 15, 2002
- Review
- 35 days
- Class
- Class II
- Product code
- GZJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K895473 (1989). 3 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK895473 DSX (TM), Digital SX, Quantum DSX, Model 4700SMedical Devices, Inc. · 1989
- This deviceK020437 Classic TensCare Rehab, Inc. · 2002
- Descendant · cites it directly · 1 of its ownK041520 Mantra Tens Model NT3Mantra Intl. (Hk), Ltd. · 2004
- Descendant · 2 generations on · 0 of its ownK091236 Mantra Combo, Model Mecs 320Mantra Intl. (Hk), Ltd. · 2009
- Descendant · cites it directly · 0 of its ownK041092 Fast Start Tens, Model FS 3001Vision Quest Industries, Inc. · 2004
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K895473 | DSX (TM), Digital SX, Quantum DSX, Model 4700S | Medical Devices, Inc. | 1989 | — |
| 0 (this device) | K020437 | Classic Tens | Care Rehab, Inc. | 2002 | — |
| +1 | K041520 | Mantra Tens Model NT3 | Mantra Intl. (Hk), Ltd. | 2004 | — |
| +2 | K091236 | Mantra Combo, Model Mecs 320 | Mantra Intl. (Hk), Ltd. | 2009 | — |
| +1 | K041092 | Fast Start Tens, Model FS 3001 | Vision Quest Industries, Inc. | 2004 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 2 | 0 |
| 2009 | 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? (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 | Decided |
|---|---|---|---|
| * | K895473 | DSX (TM), Digital SX, Quantum DSX, Model 4700SSummary page 1…03-356-2182. McLean, VA 22102 February 5, 2002 CLASSIC TENS™ TENS device Stimulator, Nerve, Transcutaneous, For Pain Relief 84GZJ; 21 CFR 882.5890. Class II Matrix I (K895473) A portable TENS device for pain control. TENS is used for symptomatic relief and management of chronic intractable pain and/or… | 1989 |
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
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.
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 is used for symptomatic relief and management of chronic intractable pain and/or as an adjunctive treatment in the management of postsurgical and posttraumatic 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/K020437 · printed Nov 6, 2026
Cite this page
510(k) Report. “K020437: Classic Tens.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K020437
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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