510(k) · Cleared
ClearedJtech Adjuster Reflex Gun
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
J-Tech Medical, Inc. · LXM Manipulator, Plunger-Like Joint
Cleared on Feb 18, 1998 after a 90-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Feb 18, 1998
- Review
- 90 days
- Class
- Class U
- Product code
- LXM
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LXM? 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 LXM device
- #1 K234036 Sonik Monark 100score 7.4 · 3 generations · no Class I recall
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
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.
How does its category compare?
All LXM devicesLXM Manipulator, Plunger-Like Joint: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LXM
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · LXM
Too few LXM 510(k)s in any year since 2007 to give a median.
Recalls per year · LXM
No recall names LXM since 2007.
Adverse event reports per year · LXM
1in 2020
MAUDE reports naming product code LXM, 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 | 1 | — | 0 | 0 |
| 2008 | 2 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 1 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 3 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 1 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The JTECH Adjuster Reflex Gun is designed to be used when the practitioner deems manual adjustment not to be effective, possible or desirable. It can be used for stimulating segments of the cervical spine, thoracic spine and lumbar spine as well as the sacrum, ilium and extremities.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K974376 · printed Nov 6, 2026
Cite this page
510(k) Report. “K974376: Jtech Adjuster Reflex Gun.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K974376
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026