510(k) · Cleared
ClearedCombocare 2000
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Xanacare Technologies, LLC · GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief
Cleared on Aug 29, 2008 as substantially equivalent to K071445 (Escada International, Inc., 2007) and 5 other predicates after a 129-day review. Its family tree reaches back 5 generations to 2000. 6 later devices descend from it.
- Decided
- Aug 29, 2008
- Review
- 129 days
- Class
- Class II
- Product code
- GZJ
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 5 generations to K001179 (2000). 16 ancestors in all, the oldest K881114 (1988). 6 later devices descend from it, 4 citing it directly.
- Root · 5 generations backK001179 Super Nova, AcubeamLight Force Therapy, Inc. · 2000
- 4 generations backK020017 Medx 1000 SeriesMedx Electronics, Inc. · 2002
- 3 generations backK032816 Quantum Light Therapy SystemStargate International, Inc. · 2004
- 2 generations backK041530 Excalibur Light Therapy System, Model Sgiex-04-001Stargate International, Inc. · 2004
- 1 generation backK050668 GRT Lite, Model 8-aGrt Solutions, Inc. · 2006
- This deviceK081141 Combocare 2000Xanacare Technologies, LLC · 2008
- Descendant · cites it directly · 2 of its ownK083202 Combocare 2000Xanacare Technologies, LLC · 2008
- Descendant · cites it directly · 1 of its ownK083822 Laser TouchoneLaser Health Technologies, LLC · 2009
- Descendant · cites it directly · 0 of its ownK160246 SimulCare II (TM)Xanacare Technologies, LLC · 2016
- Descendant · cites it directly · 0 of its ownK142025 Neurolumen PN-1000Neurolumen, LLC · 2015
- Descendant · 2 generations on · 0 of its ownK102278 Quadra Bloc Tens PlusGradient Technologies, LLC · 2011
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K083202Combocare 2000Xanacare Technologies, LLC · 2008 · cites it directly2descendants
- K083822Laser TouchoneLaser Health Technologies, LLC · 2009 · cites it directly1descendant
- K160246SimulCare II (TM)Xanacare Technologies, LLC · 2016 · cites it directly0descendants
- K142025Neurolumen PN-1000Neurolumen, LLC · 2015 · cites it directly0descendants
- K102278Quadra Bloc Tens PlusGradient Technologies, LLC · 2011 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K001179 | Super Nova, Acubeam | Light Force Therapy, Inc. | 2000 | — |
| −4 | K020017 | Medx 1000 Series | Medx Electronics, Inc. | 2002 | — |
| −3 | K032816 | Quantum Light Therapy System | Stargate International, Inc. | 2004 | — |
| −2 | K041530 | Excalibur Light Therapy System, Model Sgiex-04-001 | Stargate International, Inc. | 2004 | — |
| −1 | K050668 | GRT Lite, Model 8-a | Grt Solutions, Inc. | 2006 | — |
| 0 (this device) | K081141 | Combocare 2000 | Xanacare Technologies, LLC | 2008 | — |
| +1 | K083202 | Combocare 2000 | Xanacare Technologies, LLC | 2008 | — |
| +1 | K083822 | Laser Touchone | Laser Health Technologies, LLC | 2009 | — |
| +1 | K160246 | SimulCare II (TM) | Xanacare Technologies, LLC | 2016 | — |
| +1 | K142025 | Neurolumen PN-1000 | Neurolumen, LLC | 2015 | — |
| +2 | K102278 | Quadra Bloc Tens Plus | Gradient Technologies, LLC | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2002 | 4 | 0 |
| 2005 | 1 | 0 |
| 2007 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 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? (6)
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 |
|---|---|---|---|
| * | K071445 | Terraquant MQ2000 V.5 with the TQ-1TENSSummary page 2…uses higher power laser IR diodes and does not include a vibrator. The ComboCare 2000 has technological characteristics similar to the following predicate device(s): * K071445 Escada International, Inc. TerraQuant MQ2000 v.5 with TQ-ITENS * K021755 Apex Medical Corp., Apex TSI211 * K061650 LMPI, EMPI… | 2007 |
| * | K021755 | Apex Medical Digital Tens TS1211, TS1212Summary page 2…oCare 2000 has technological characteristics similar to the following predicate device(s): * K071445 Escada International, Inc. TerraQuant MQ2000 v.5 with TQ-ITENS * K021755 Apex Medical Corp., Apex TSI211 * K061650 LMPI, EMPI Select TENS * K041530 Excalibur Light Iherapy System * K041565 Lazr Pu… | 2002 |
| * | K061650 | Select Tens, Model 4600SSummary page 2…similar to the following predicate device(s): * K071445 Escada International, Inc. TerraQuant MQ2000 v.5 with TQ-ITENS * K021755 Apex Medical Corp., Apex TSI211 * K061650 LMPI, EMPI Select TENS * K041530 Excalibur Light Iherapy System * K041565 Lazr Pulsr 4x * K050668 GRT LITE Model 8-A Light… | 2007 |
| * | K041530 | Excalibur Light Therapy System, Model Sgiex-04-001Summary page 2…device(s): * K071445 Escada International, Inc. TerraQuant MQ2000 v.5 with TQ-ITENS * K021755 Apex Medical Corp., Apex TSI211 * K061650 LMPI, EMPI Select TENS * K041530 Excalibur Light Iherapy System * K041565 Lazr Pulsr 4x * K050668 GRT LITE Model 8-A Light Therapy System Summary of Technolo… | 2004 |
| * | K041565 | Lazrpulsr 4XSummary page 2…l, Inc. TerraQuant MQ2000 v.5 with TQ-ITENS * K021755 Apex Medical Corp., Apex TSI211 * K061650 LMPI, EMPI Select TENS * K041530 Excalibur Light Iherapy System * K041565 Lazr Pulsr 4x * K050668 GRT LITE Model 8-A Light Therapy System Summary of Technological Characteristics Compared to Predicate… | 2005 |
| * | K050668 | GRT Lite, Model 8-aSummary page 2…v.5 with TQ-ITENS * K021755 Apex Medical Corp., Apex TSI211 * K061650 LMPI, EMPI Select TENS * K041530 Excalibur Light Iherapy System * K041565 Lazr Pulsr 4x * K050668 GRT LITE Model 8-A Light Therapy System Summary of Technological Characteristics Compared to Predicate Devices… | 2006 |
What descends from it? (6)
4 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 8 years and passes through 5 companies; a new generation was cleared every 1.7 years on median.
- None of the 16 ancestors has a recall.
- Of its descendants, K083202 (Xanacare Technologies, LLC, 2008) has gone furthest, with 2 descendants of its own.
- 3 other devices also cite its predicate K071445.
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. 2008, 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?
The ComboCare 2000 is intended for the temporary relief of minor muscle and joint pain,
promoting relaxation of muscle tissue, symptomatic relief and management of chronic
intractable pain, and adjunctive relief of post-surgical or post-traumatic acute pain.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081141 · printed Nov 5, 2026
Cite this page
510(k) Report. “K081141: Combocare 2000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K081141
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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