510(k) · Cleared
ClearedSimulCare II (TM)
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 Oct 6, 2016 as substantially equivalent to K083202 (Xanacare Technologies, LLC, 2008) and 1 other predicate after a 248-day review. Its family tree reaches back 7 generations to 2000.
- Decided
- Oct 6, 2016
- Review
- 248 days
- Class
- Class II
- Product code
- GZJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K001179 (2000). 18 ancestors in all, the oldest K881114 (1988). No later device cites it as a predicate yet.
- Root · 7 generations backK001179 Super Nova, AcubeamLight Force Therapy, Inc. · 2000
- 6 generations backK020017 Medx 1000 SeriesMedx Electronics, Inc. · 2002
- 5 generations backK032816 Quantum Light Therapy SystemStargate International, Inc. · 2004
- 4 generations backK041530 Excalibur Light Therapy System, Model Sgiex-04-001Stargate International, Inc. · 2004
- 3 generations backK050668 GRT Lite, Model 8-aGrt Solutions, Inc. · 2006
- 2 generations backK081141 Combocare 2000Xanacare Technologies, LLC · 2008
- 1 generation backK083202 Combocare 2000Xanacare Technologies, LLC · 2008
- This deviceK160246 SimulCare II (TM)Xanacare Technologies, LLC · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K001179 | Super Nova, Acubeam | Light Force Therapy, Inc. | 2000 | — |
| −6 | K020017 | Medx 1000 Series | Medx Electronics, Inc. | 2002 | — |
| −5 | K032816 | Quantum Light Therapy System | Stargate International, Inc. | 2004 | — |
| −4 | K041530 | Excalibur Light Therapy System, Model Sgiex-04-001 | Stargate International, Inc. | 2004 | — |
| −3 | K050668 | GRT Lite, Model 8-a | Grt Solutions, Inc. | 2006 | — |
| −2 | K081141 | Combocare 2000 | Xanacare Technologies, LLC | 2008 | — |
| −1 | K083202 | Combocare 2000 | Xanacare Technologies, LLC | 2008 | — |
| 0 (this device) | K160246 | SimulCare II (TM) | Xanacare Technologies, LLC | 2016 | — |
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 |
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 |
|---|---|---|---|
| * | K083202 | Combocare 2000Summary page 4…Product code: ILY & name: Pain Relief ISA Predicate K083202, K081141 devices: Device description: The SimulCare II Multi-function Therapeutic Device is modified from the SimulCare and Combo… | 2008 |
| * | K081141 | Combocare 2000Summary page 4…t code: ILY & name: Pain Relief ISA Predicate K083202, K081141 devices: Device description: The SimulCare II Multi-function Therapeutic Device is modified from the SimulCare and ComboCare 2000… | 2008 |
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 16 years and passes through 5 companies; a new generation was cleared every 1.7 years on median.
- None of the 18 ancestors has a recall.
- 1 other device also cites its predicate K083202.
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. 2016, 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 SimulCare II™ is intended for the temporary relief of minor muscle and joint pain, promoting the relaxation of
muscle tissue, temporarily increasing local blood circulation, symptomatic relief and management of chronic intractable
pain, and adjunctive relief of post-surgical or post-traumatic pain.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K160246 · printed Nov 6, 2026
Cite this page
510(k) Report. “K160246: SimulCare II (TM).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K160246
Report an extraction error
Are you the manufacturer?
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