510(k) · Cleared
ClearedVectra Pro Models 2 and 4
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Chattanooga Group, Inc. · GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief
Cleared on Feb 1, 1999 after a 214-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 67 later devices descend from it.
- Decided
- Feb 1, 1999
- Review
- 214 days
- Class
- Class II
- Product code
- GZJ
- Recalls
- None
- Predicates
- 0
67 later devices descend from it, 4 citing it directly.
- This deviceK982324 Vectra Pro Models 2 and 4Chattanooga Group, Inc. · 1999
- Descendant · cites it directly · 63 of its ownK023231 Elfcare Device, Models 314A Through 314GMediseb, Ltd. · 2003
- Descendant · 2 generations on · 35 of its ownK063715 Juniper Cooling Device XtraJuniper Medical, Inc. · 2007
- Descendant · 2 generations on · 34 of its ownK072152 Juniper CLN1 Dermal Cooling DeviceJuniper Medical, Inc. · 2007
- Descendant · 3 generations on · 33 of its ownK080118 Zeltiq Aesthetics CLN1 Dermal Cooling DeviceZeltiq Aesthetics · 2008
- Descendant · 4 generations on · 32 of its ownK090094 Zeltiq SystemZeltiq Aesthetics · 2009
Showing 5 of 67 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 67 · See all- K023231Elfcare Device, Models 314A Through 314GMediseb, Ltd. · 2003 · cites it directly63descendants
- K063715Juniper Cooling Device XtraJuniper Medical, Inc. · 2007 · 2 generations on35descendants
- K072152Juniper CLN1 Dermal Cooling DeviceJuniper Medical, Inc. · 2007 · 2 generations on34descendants
- K080118Zeltiq Aesthetics CLN1 Dermal Cooling DeviceZeltiq Aesthetics · 2008 · 3 generations on33descendants
- K090094Zeltiq SystemZeltiq Aesthetics · 2009 · 4 generations on32descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K982324 | Vectra Pro Models 2 and 4 | Chattanooga Group, Inc. | 1999 | — |
| +1 | K023231 | Elfcare Device, Models 314A Through 314G | Mediseb, Ltd. | 2003 | — |
| +2 | K063715 | Juniper Cooling Device Xtra | Juniper Medical, Inc. | 2007 | — |
| +2 | K072152 | Juniper CLN1 Dermal Cooling Device | Juniper Medical, Inc. | 2007 | — |
| +3 | K080118 | Zeltiq Aesthetics CLN1 Dermal Cooling Device | Zeltiq Aesthetics | 2008 | — |
| +4 | K090094 | Zeltiq System | Zeltiq Aesthetics | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 3 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 4 | 0 |
| 2016 | 3 | 0 |
| 2017 | 5 | 0 |
| 2018 | 1 | 0 |
| 2019 | 7 | 0 |
| 2020 | 6 | 0 |
| 2021 | 7 | 0 |
| 2022 | 7 | 0 |
| 2023 | 9 | 0 |
| 2024 | 4 | 0 |
| 2025 | 2 | 0 |
| 2026 | 1 | 0 |
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 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’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (67)
See all 674 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, K023231 (Mediseb, Ltd., 2003) has gone furthest, with 63 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?
For Ultrasound Ultrasound for use in applying deep heat can be used for treatment of selected medical conditions such as the relief of pain, muscle spasms and joint contractures. These conditions may be associated with adhesive capsulitis, bursitis with slight calcification, myositis and soft tissue injuries. Ultrasound can provide therapeutic deep heating between 40° and 45 °C. For VMS, Russian, Monophasic Hi-Volt Relaxation of muscle spasms Prevention…
Read the full statement (114 words)
For Ultrasound
Ultrasound for use in applying deep heat can be used for treatment of selected medical conditions such as the relief of pain, muscle spasms and joint contractures. These conditions may be associated with adhesive capsulitis, bursitis with slight calcification, myositis and soft tissue injuries. Ultrasound can provide therapeutic deep heating between 40° and 45 °C.
For VMS, Russian, Monophasic Hi-Volt
Relaxation of muscle spasms
Prevention or retardation of disuse atrophy
Increasing local blood circulation
Muscle re-education
Maintaining or increasing range of motion
Immediate postsurgical stimulation of calf muscles to prevent venous thrombosis
For Microcurrent, Interferential and Premodulated
Symptomatic relief of chronic, intractable pain
Management of pain associated with post-traumatic or post-operative conditions
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/K982324 · printed Nov 4, 2026
Cite this page
510(k) Report. “K982324: Vectra Pro Models 2 and 4.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K982324
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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