510(k) · Cleared
ClearedWellnesspro 2010
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Intelsource Group, Inc. · GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief
Cleared on Jul 6, 2007 as substantially equivalent to K060669 (Healthonics, Inc., 2006) and 1 other predicate after a 304-day review. Its family tree reaches back 3 generations to 1997.
- Decided
- Jul 6, 2007
- Review
- 304 days
- Class
- Class II
- Product code
- GZJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K971437 (1997). 11 ancestors in all, the oldest K923914 (1992). No later device cites it as a predicate yet.
- Root · 3 generations backK971437 Bionicare Stimulator System. Model Bio-1000Murray Electronics · 1997
- 2 generations backK983228 Bionicare Stimilator System, Model Bio-1000Murray Electronics · 1999
- 1 generation backK060669 Medrelief ST Series, Models RT-50, ST-100, ST 150, ST-200, ST-300Healthonics, Inc. · 2006
- This deviceK062616 Wellnesspro 2010Intelsource Group, Inc. · 2007
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K971437 | Bionicare Stimulator System. Model Bio-1000 | Murray Electronics | 1997 | — |
| −2 | K983228 | Bionicare Stimilator System, Model Bio-1000 | Murray Electronics | 1999 | — |
| −1 | K060669 | Medrelief ST Series, Models RT-50, ST-100, ST 150, ST-200, ST-300 | Healthonics, Inc. | 2006 | — |
| 0 (this device) | K062616 | Wellnesspro 2010 | Intelsource Group, Inc. | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1994 | 1 | 0 |
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
| 2001 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 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 |
|---|---|---|---|
| * | K060669 | Medrelief ST Series, Models RT-50, ST-100, ST 150, ST-200, ST-300 Cleared while this submission was under review Summary page 1…Identification: 21CFR:882.5890 Product Code: GZJ Device Class: 11 Legally Marketed Device: Medrelief ST-100, ST-15O, ST-200, ST-300 Manufacturer: Healthonics, Inc. Kgt: K060669 21CFR:882. 5890 Product Code: GZJ Device Class: II Legally Marketed Device: Fenzian Treatment System Manufacturer: Eumedic, Ltd… | 2006 |
| * | K041575 | Fenzian Treatment SystemSummary page 1…rer: Healthonics, Inc. Kgt: K060669 21CFR:882. 5890 Product Code: GZJ Device Class: II Legally Marketed Device: Fenzian Treatment System Manufacturer: Eumedic, Ltd K#: K041575 Device Description The Wellness Pro 2010 is designed to provide electrical stimulation, for the relief of chroni… | 2004 |
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 10 years and passes through 3 companies; a new generation was cleared every 1.6 years on median.
- None of the 11 ancestors has a recall.
- 1 other device also cites its predicate K060669.
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. 2007, 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 Wellness Pro 2010 is an Electrotherapy Unit that is used for the following:
1. Relief of chronic, intractable pain.
2. Adjunctive treatment of post surgical or post-traumatic acute pain
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062616 · printed Nov 6, 2026
Cite this page
510(k) Report. “K062616: Wellnesspro 2010.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K062616
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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