510(k) · Cleared
ClearedElfcare Device, Models 314A Through 314G
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mediseb, Ltd. · GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief
Cleared on Apr 4, 2003 as substantially equivalent to K982324 (Chattanooga Group, Inc., 1999) and 3 other predicates after a 189-day review. Its family tree reaches back 3 generations to 1991. 63 later devices descend from it.
- Decided
- Apr 4, 2003
- Review
- 189 days
- Class
- Class II
- Product code
- GZJ
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 3 generations to K912178 (1991). 10 ancestors in all, the oldest K880042 (1988). 63 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK912178 Bio Tens 601, 606 and 608 (3000)Skylark Device Co., Ltd. · 1991
- 2 generations backK972244 NT2000Bio-Medical Research, Ltd. · 1998
- 1 generation backK990787 TRIO 300Ito Co., Ltd. · 1999
- This deviceK023231 Elfcare Device, Models 314A Through 314GMediseb, Ltd. · 2003
- Descendant · cites it directly · 35 of its ownK063715 Juniper Cooling Device XtraJuniper Medical, Inc. · 2007
- Descendant · cites it directly · 34 of its ownK072152 Juniper CLN1 Dermal Cooling DeviceJuniper Medical, Inc. · 2007
- Descendant · 2 generations on · 33 of its ownK080118 Zeltiq Aesthetics CLN1 Dermal Cooling DeviceZeltiq Aesthetics · 2008
- Descendant · 3 generations on · 32 of its ownK090094 Zeltiq SystemZeltiq Aesthetics · 2009
- Descendant · 4 generations on · 31 of its ownK120023 Zeltiq CoolsculptingZeltiq Aesthetics, Inc. · 2012
Showing 5 of 63 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 63 · See all- K063715Juniper Cooling Device XtraJuniper Medical, Inc. · 2007 · cites it directly35descendants
- K072152Juniper CLN1 Dermal Cooling DeviceJuniper Medical, Inc. · 2007 · cites it directly34descendants
- K080118Zeltiq Aesthetics CLN1 Dermal Cooling DeviceZeltiq Aesthetics · 2008 · 2 generations on33descendants
- K090094Zeltiq SystemZeltiq Aesthetics · 2009 · 3 generations on32descendants
- K120023Zeltiq CoolsculptingZeltiq Aesthetics, Inc. · 2012 · 4 generations on31descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K912178 | Bio Tens 601, 606 and 608 (3000) | Skylark Device Co., Ltd. | 1991 | — |
| −2 | K972244 | NT2000 | Bio-Medical Research, Ltd. | 1998 | — |
| −1 | K990787 | TRIO 300 | Ito Co., Ltd. | 1999 | — |
| 0 (this device) | K023231 | Elfcare Device, Models 314A Through 314G | Mediseb, Ltd. | 2003 | — |
| +1 | K063715 | Juniper Cooling Device Xtra | Juniper Medical, Inc. | 2007 | — |
| +1 | K072152 | Juniper CLN1 Dermal Cooling Device | Juniper Medical, Inc. | 2007 | — |
| +2 | K080118 | Zeltiq Aesthetics CLN1 Dermal Cooling Device | Zeltiq Aesthetics | 2008 | — |
| +3 | K090094 | Zeltiq System | Zeltiq Aesthetics | 2009 | — |
| +4 | K120023 | Zeltiq Coolsculpting | Zeltiq Aesthetics, Inc. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1991 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (5)
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 |
|---|---|---|---|
| * | K982324 | Vectra Pro Models 2 and 4Summary page 2…Hot/Cold Pack, Class I, 890.5700 Page 2 of 5 Predicate Devices: Vectra PRO 2 I Chattanooga Group Inc. I Electrotherapy Device 1 K982324 Trio 300 I I T 0 CO., Ltd. 1 Electrotherapy Device I K990787 1 Thera-Temp Flexible Cold/… | 1999 |
| * | K990787 | TRIO 300Summary page 2…Vectra PRO 2 I Chattanooga Group Inc. I Electrotherapy Device 1 K982324 Trio 300 I I T 0 CO., Ltd. 1 Electrotherapy Device I K990787 1 Thera-Temp Flexible Cold/Hot Packs Chattanooga group Inc.… | 1999 |
| * | K913026 | Ttu-100THERMAL Therapy UnitSummary page 2…up Inc. 1 ColdPack Artothenn Thermal Therapy K913026 Cryotherapy and Ormed GmbH Device Thermotherapy… | 1991 |
| * | K964799 | Artrotherm Cryotherapy and ThernotherapySummary page 2…Thermotherapy Danninger Medical Thermal Therapy TTU- 100 K964799 Technology Inc. Device Description of the Device: The ELFcareTMdevice is a lightweig… | 1997 |
| * | — | Thera-Temp Flexible Cold/Hot Packs Named without a submission number |
What descends from it? (63)
See all 633 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?
- The line of descent spans 12 years and passes through 4 companies; a new generation was cleared every 3.5 years on median.
- None of the 10 ancestors has a recall.
- Of its descendants, K063715 (Juniper Medical, Inc., 2007) has gone furthest, with 35 descendants of its own.
- 3 other devices also cite its predicate K982324.
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 Microcurrent and IFC (Premodulated Interferential) electrical stimulation using models 314A, 314B, 314C, 314F and 314G: - Symptomatic relief and management of chronic intractable pain - Adjunctive treatment in the management of post-surgical and post-traumatic pain. For VMS Burst, Russian and Biphasic Symmetrical Pulses electrical stimulation using models 314F and 314G: - Relaxation of muscle spasms - Prevention or retardation of disuse atrophy -…
Read the full statement (128 words)
For Microcurrent and IFC (Premodulated Interferential) electrical stimulation using models 314A, 314B, 314C, 314F and 314G:
- Symptomatic relief and management of chronic intractable pain
- Adjunctive treatment in the management of post-surgical and post-traumatic pain.
For VMS Burst, Russian and Biphasic Symmetrical Pulses electrical stimulation using models 314F and 314G:
- Relaxation of muscle spasms
- Prevention or retardation of disuse atrophy
- Increasing local blood circulation
- Muscle re-education
- Maintaining or increasing range of motion
- Prevention of venous thrombosis of the calf muscles immediately after surgery
For HotKold therapy using models: 314A, 314B, 314C, 314D, 314E:
- Localized thermal therapy (hot or cold) for post traumatic and post surgical medical and/or surgical conditions.
- Temporary relief of minor aches and pains and muscle spasms
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K023231 · printed Nov 6, 2026
Cite this page
510(k) Report. “K023231: Elfcare Device, Models 314A Through 314G.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023231
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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