510(k) · Cleared
ClearedNeuromed Electroanalgesic Delivery Systems
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aa Neuromed Corp. · GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief
Cleared on Aug 18, 2009 as substantially equivalent to K932897 (Nemectron GmbH, 1994) after a 287-day review. Its family tree reaches back 1 generation to 1994.
- Decided
- Aug 18, 2009
- Review
- 287 days
- Class
- Class II
- Product code
- GZJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K932897 (1994). No later device cites it as a predicate yet.
- Root · 1 generation backK932897 Transcutaneous Electrical Nerve StimulatorNemectron GmbH · 1994
- This deviceK083250 Neuromed Electroanalgesic Delivery SystemsAa Neuromed Corp. · 2009
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K932897 | Transcutaneous Electrical Nerve Stimulator | Nemectron GmbH | 1994 | — |
| 0 (this device) | K083250 | Neuromed Electroanalgesic Delivery Systems | Aa Neuromed Corp. | 2009 | — |
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K932897 | Transcutaneous Electrical Nerve StimulatorSummary page 1…al Current Therapy Device, Product Code: LIH (Unclassified), IPF, GZJ Predicate Devices Information: TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR (Nemectron EDiT) (K932897), Metron Vectorsurge 5 (K03048) Device Description: NeuroMed Electroanalgesic Delivery Systems consist of a system console with… | 1994 |
| Kept off the family tree | K030048 | FDA’s K030048 is HA Pmi Femoral Hip Stem Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2003 |
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?
- Its one ancestor has no recall.
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. 2009, 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?
Pain Management for use with interferential and/or TENS mode programs/parameters
Stimulate peripheral nerves for the purpose of providing pain relief.
Management and symptomatic relief of chronic (long-term) intractable pain.
Adjunctive treatment of post-traumatic pain.
Adjunctive treatment in the management of post-surgical pain.
Muscle Stimulation for use with muscle stimulation programs
Increasing local blood circulation.
Maintaining or increasing range of motion.
Muscle Re-education.
Relaxation of muscle spasms.
Prevention or retardation of disuse atrophy.
Immediate post-surgical stimulation of the calf muscles to prevent venous thrombosis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083250 · printed Nov 4, 2026
Cite this page
510(k) Report. “K083250: Neuromed Electroanalgesic Delivery Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K083250
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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