510(k) · Cleared
ClearedMedrelief ST Series, Models RT-50, ST-100, ST 150, ST-200, ST-300
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Healthonics, Inc. · GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief
Cleared on Oct 13, 2006 as substantially equivalent to K030998 (Healthonics, Inc., 2003) and 2 other predicates after a 213-day review. Its family tree reaches back 2 generations to 1997. 2 later devices descend from it.
- Decided
- Oct 13, 2006
- Review
- 213 days
- Class
- Class II
- Product code
- GZJ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K971437 (1997). 8 ancestors in all, the oldest K923914 (1992). 2 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK971437 Bionicare Stimulator System. Model Bio-1000Murray Electronics · 1997
- 1 generation backK983228 Bionicare Stimilator System, Model Bio-1000Murray Electronics · 1999
- This deviceK060669 Medrelief ST Series, Models RT-50, ST-100, ST 150, ST-200, ST-300Healthonics, Inc. · 2006
- Descendant · cites it directly · 0 of its ownK062616 Wellnesspro 2010Intelsource Group, Inc. · 2007
- Descendant · cites it directly · 0 of its ownK062325 RS-4I Muscle Stimulator FamilyRs Medical · 2007
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K971437 | Bionicare Stimulator System. Model Bio-1000 | Murray Electronics | 1997 | — |
| −1 | K983228 | Bionicare Stimilator System, Model Bio-1000 | Murray Electronics | 1999 | — |
| 0 (this device) | K060669 | Medrelief ST Series, Models RT-50, ST-100, ST 150, ST-200, ST-300 | Healthonics, Inc. | 2006 | — |
| +1 | K062616 | Wellnesspro 2010 | Intelsource Group, Inc. | 2007 | — |
| +1 | K062325 | RS-4I Muscle Stimulator Family | Rs Medical | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1994 | 1 | 0 |
| 1998 | 1 | 0 |
| 2001 | 1 | 0 |
| 2003 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (3)
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 |
|---|---|---|---|
| * | K030998 | Medrelief SE Series, Models SE-50, SE-100, SE-200, SE-300Summary page 1…duct Code NYN (prescription). Predicate Devices: Healthonics MedRelief® SE-50 for acute and chronic pain indications (K030998). Bionicare Model BIO-1000 for osteoarthritis (K030332) an… | 2003 |
| * | K030332 | Modification to Bionicare Stimulator System, Model Bio-1000Summary page 1…pain indications (K030998). Bionicare Model BIO-1000 for osteoarthritis (K030332) and rheumatoid arthritis (K983228) indications. Description of theDevice: The MedRelief ®… | 2003 |
| * | K983228 | Bionicare Stimilator System, Model Bio-1000Summary page 1…cations (K030998). Bionicare Model BIO-1000 for osteoarthritis (K030332) and rheumatoid arthritis (K983228) indications. Description of theDevice: The MedRelief ®ST Series TM,consisting of models S… | 1999 |
What descends from it? (2)
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 9 years and passes through 2 companies; a new generation was cleared every 7.6 years on median.
- None of the 8 ancestors has a recall.
- Of its descendants, K062616 (Intelsource Group, Inc., 2007) has gone furthest, with 0 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.
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?
Relief of chronic intractable pain.
Adjunctive treatment of post-surgical or post-traumatic acute pain.
Relief of chronic intractable pain.
Adjunctive treatment of post-surgical or post-traumatic acute pain.
Adjunctive therapy in reducing the level of pain associated with osteoarthritis of the knee.
Adjunctive therapy in reducing the level of pain from rheumatoid arthritis of the hand.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060669 · printed Nov 6, 2026
Cite this page
510(k) Report. “K060669: Medrelief ST Series, Models RT-50, ST-100, ST 150, ST-200, ST-300.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K060669
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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