510(k) · Cleared
ClearedActicare IC and Tse
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bioinduction Limited · GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief
Cleared on Mar 19, 2009 as substantially equivalent to K003744 (Henley Healthcare, Inc., 2002) and 4 other predicates after a 265-day review. Its family tree reaches back 2 generations to 1987. 3 later devices descend from it.
- Decided
- Mar 19, 2009
- Review
- 265 days
- Class
- Class II
- Product code
- GZJ
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 2 generations to K872657 (1987). 10 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK872657 Ultrapac II SX Plus (TM)Medical Devices, Inc. · 1987
- 1 generation backK022405 Modification to Promax-XP, Tens and Microcurrent Device…Rehabilicare, Inc. · 2002
- This deviceK081835 Acticare IC and TseBioinduction Limited · 2009
- Descendant · cites it directly · 2 of its ownK161091 STIMPOD NMS460 Nerve StimulatorXavant Technology (Pty), Ltd. · 2017
- Descendant · 2 generations on · 0 of its ownK252712 STIMPOD NMS460 Nerve StimulatorAlgiamed Technologies USA, Inc. · 2026
- Descendant · cites it directly · 0 of its ownK213802 StimOnTM Pain Relief System (GM2439)Gimer Medical Co., Ltd. · 2022
Most influential descendants
Showing 3 of 3 · See all- K161091STIMPOD NMS460 Nerve StimulatorXavant Technology (Pty), Ltd. · 2017 · cites it directly2descendants
- K252712STIMPOD NMS460 Nerve StimulatorAlgiamed Technologies USA, Inc. · 2026 · 2 generations on0descendants
- K213802StimOnTM Pain Relief System (GM2439)Gimer Medical Co., Ltd. · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K872657 | Ultrapac II SX Plus (TM) | Medical Devices, Inc. | 1987 | — |
| −1 | K022405 | Modification to Promax-XP, Tens and Microcurrent Device; Promax-Tens, Tens… | Rehabilicare, Inc. | 2002 | — |
| 0 (this device) | K081835 | Acticare IC and Tse | Bioinduction Limited | 2009 | — |
| +1 | K161091 | STIMPOD NMS460 Nerve Stimulator | Xavant Technology (Pty), Ltd. | 2017 | — |
| +2 | K252712 | STIMPOD NMS460 Nerve Stimulator | Algiamed Technologies USA, Inc. | 2026 | — |
| +1 | K213802 | StimOnTM Pain Relief System (GM2439) | Gimer Medical Co., Ltd. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1998 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2022 | 1 | 0 |
| 2026 | 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K003744 | Enraf-Nonius Endomed 182 SystemSummary page 1…predicate devices: As a TENS device under classification GZJ: 1. EnrafNonius Endomed 182 System (k003744), 2. Skylark PGS-123 High Voltage Galvanic Stimulator (k946299)… | 2002 |
| * | K946299 | PGS123 and HVS-123Summary page 1…1. EnrafNonius Endomed 182 System (k003744), 2. Skylark PGS-123 High Voltage Galvanic Stimulator (k946299) 3. Rehabilicare (now Compex Technologies Inc.) ProMax TENS… | 1995 |
| * | K022405 | Modification to Promax-XP, Tens and Microcurrent Device; Promax-Tens, Tens Device…Summary page 1…ltage Galvanic Stimulator (k946299) 3. Rehabilicare (now Compex Technologies Inc.) ProMax TENS (k022405) 4. Body Clock Health Care Ltd V-TENS Plus (k022731) As a… | 2002 |
| * | K022731 | V Tens PlusSummary page 1…(now Compex Technologies Inc.) ProMax TENS (k022405) 4. Body Clock Health Care Ltd V-TENS Plus (k022731) As a NMES device under classification IPF 5. BioStim NMS+… | 2002 |
| * | K010749 | Electro Neuromuscular Stimulator, Model NMS-DigitalSummary page 1…31) As a NMES device under classification IPF 5. BioStim NMS+ Electrical Neuromuscular Stimulator (k010749) Device Description: Acticare H-FT/HFI is a hand-held stimulator designed to pass electrical… | 2001 |
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?
- The line of descent spans 22 years and passes through 3 companies; a new generation was cleared every 15.0 years on median.
- None of the 10 ancestors has a recall.
- Of its descendants, K161091 (Xavant Technology (Pty), Ltd., 2017) has gone furthest, with 2 descendants of its own.
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?
As a Transcutaneous Electronic Nerve Stimulation (TENS) device for:
the symptomatic relief of chronic intractable pain,
and
as an adjunctive treatment in the management of post-surgical or post-traumatic pain.
As a Neuromuscular Electrostimulation (NMES) device for:
the relaxation of muscle spasms,
prevention or retardation of disuse atrophy,
increasing local blood circulation,
muscle re-education,
immediate post-surgical stimulation of the calf muscles to prevent venous thrombosis
and
to maintain or increase the range of motion.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081835 · printed Nov 4, 2026
Cite this page
510(k) Report. “K081835: Acticare IC and Tse.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K081835
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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