510(k) · Cleared
Cleared804SIII; 804W; Libra Tens; 410; S-Tens II
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Body Clock Health Care, Ltd. · GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief
Cleared on Nov 22, 2002 as substantially equivalent to K893874 (Altoona Medical Supply, 1989) and 1 other predicate after a 170-day review. Its family tree reaches back 1 generation to 1985.
- Decided
- Nov 22, 2002
- Review
- 170 days
- Class
- Class II
- Product code
- GZJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K853719 (1985). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK853719 Transcutaneous Elect. Nerve Stimul-Myostim 410Electro Therapeutic Devices, Inc. · 1985
- This deviceK021846 804SIII; 804W; Libra Tens; 410; S-Tens IIBody Clock Health Care, Ltd. · 2002
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K853719 | Transcutaneous Elect. Nerve Stimul-Myostim 410 | Electro Therapeutic Devices, Inc. | 1985 | — |
| 0 (this device) | K021846 | 804SIII; 804W; Libra Tens; 410; S-Tens II | Body Clock Health Care, Ltd. | 2002 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 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 |
|---|---|---|---|
| * | K893874 | Fujitens IiiSummary page 1…r, Nerve, Transcutaneous, For Pain Relief. 10.3 Predicate Device Information: The 804Slll, 804W, Libra TENS, 410 and S-TENSII are equivalent to the FUJI TENS 804SIII (K893874). The 804W and Libra TENS also have pulse width adjustment. The 410 is also equivalent to the FUJI TENS Myostim 410 (K853719) 10… | 1989 |
| * | K853719 | Transcutaneous Elect. Nerve Stimul-Myostim 410Summary page 1…SII are equivalent to the FUJI TENS 804SIII (K893874). The 804W and Libra TENS also have pulse width adjustment. The 410 is also equivalent to the FUJI TENS Myostim 410 (K853719) 10.4 Device Description: The TENS devices are used to transmit electrical pulses through the skin to the underlying peripheral… | 1985 |
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 2 ancestors has a recall.
- 4 other devices also cite its predicate K893874.
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?
The 804Sll1, 804W, Libra TENS, 410 and S-TENSII are 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/K021846 · printed Nov 4, 2026
Cite this page
510(k) Report. “K021846: 804SIII; 804W; Libra Tens; 410; S-Tens II.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K021846
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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