510(k) · Cleared
ClearedCefar Medical AB Cefar Primo
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cefar Medical AB · GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief
Cleared on Jun 10, 2002 as substantially equivalent to K982410 (Rehabilicare, Inc., 1998) after a 90-day review. Its family tree reaches back 1 generation to 1998. 3 later devices descend from it.
- Decided
- Jun 10, 2002
- Review
- 90 days
- Class
- Class II
- Product code
- GZJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K982410 (1998). 3 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK982410 SMP-Plus,SX-Plus,SX Model # 49XX Series 9 Volt Tens DeviceRehabilicare, Inc. · 1998
- This deviceK020803 Cefar Medical AB Cefar PrimoCefar Medical AB · 2002
- Descendant · cites it directly · 2 of its ownK032928 Mediphysics Pain Treatment System, Model 1Mediphysics Pain Centers of America · 2003
- Descendant · cites it directly · 1 of its ownK070474 Newlife Sciences LLC, Model TMRNewlife Sciences, LLC · 2007
- Descendant · 2 generations on · 0 of its ownK202186 TrueRelief DeviceTruerelief · 2021
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K982410 | SMP-Plus,SX-Plus,SX Model # 49XX Series 9 Volt Tens Device | Rehabilicare, Inc. | 1998 | — |
| 0 (this device) | K020803 | Cefar Medical AB Cefar Primo | Cefar Medical AB | 2002 | — |
| +1 | K032928 | Mediphysics Pain Treatment System, Model 1 | Mediphysics Pain Centers of America | 2003 | — |
| +1 | K070474 | Newlife Sciences LLC, Model TMR | Newlife Sciences, LLC | 2007 | — |
| +2 | K202186 | TrueRelief Device | Truerelief | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2007 | 1 | 0 |
| 2021 | 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? (1)
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 |
|---|---|---|---|
| * | K982410 | SMP-Plus,SX-Plus,SX Model # 49XX Series 9 Volt Tens Device | 1998 |
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?
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?
TENS stimulation is used for symptomatic relief and management of chronic intractable
pain. It is also used as an adjunctive treatment in the management of post-surgical and
post-traumatic pain. It has no curative value and should be used only in conjunction with
medical supervision.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K020803 · printed Nov 6, 2026
Cite this page
510(k) Report. “K020803: Cefar Medical AB Cefar Primo.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K020803
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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