510(k) · Cleared
ClearedElectro-Acuscope 85
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomedical Design Instruments · GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief
Cleared on Feb 2, 1990 after a 505-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 5 later devices descend from it.
- Decided
- Feb 2, 1990
- Review
- 505 days
- Class
- Class II
- Product code
- GZJ
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 3 citing it directly.
- This deviceK883911 Electro-Acuscope 85Biomedical Design Instruments · 1990
- 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 ownK083822 Laser TouchoneLaser Health Technologies, LLC · 2009
- 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
- Descendant · 2 generations on · 0 of its ownK100116 Lasertouchone (Otc)Laser Health Technologies, LLC · 2010
Most influential descendants
Showing 5 of 5 · See all- K032928Mediphysics Pain Treatment System, Model 1Mediphysics Pain Centers of America · 2003 · cites it directly2descendants
- K083822Laser TouchoneLaser Health Technologies, LLC · 2009 · cites it directly1descendant
- K070474Newlife Sciences LLC, Model TMRNewlife Sciences, LLC · 2007 · cites it directly1descendant
- K202186TrueRelief DeviceTruerelief · 2021 · 2 generations on0descendants
- K100116Lasertouchone (Otc)Laser Health Technologies, LLC · 2010 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K883911 | Electro-Acuscope 85 | Biomedical Design Instruments | 1990 | — |
| +1 | K032928 | Mediphysics Pain Treatment System, Model 1 | Mediphysics Pain Centers of America | 2003 | — |
| +1 | K083822 | Laser Touchone | Laser Health Technologies, LLC | 2009 | — |
| +1 | K070474 | Newlife Sciences LLC, Model TMR | Newlife Sciences, LLC | 2007 | — |
| +2 | K202186 | TrueRelief Device | Truerelief | 2021 | — |
| +2 | K100116 | Lasertouchone (Otc) | Laser Health Technologies, LLC | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2021 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (5)
3 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?
- Of its descendants, K032928 (Mediphysics Pain Centers of America, 2003) has gone furthest, with 2 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 | — |
https://510kreport.com/device/K883911 · printed Nov 6, 2026
Cite this page
510(k) Report. “K883911: Electro-Acuscope 85.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K883911
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026