510(k) · Cleared
ClearedEzfit Digital Heating Tens (Model NO.: HR-661/UC-101)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ezfit Technology, Inc. · GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief
Cleared on Jul 16, 2007 as substantially equivalent to K023231 (Mediseb, Ltd., 2003) and 1 other predicate after a 166-day review. Its family tree reaches back 4 generations to 1991. 26 later devices descend from it.
- Decided
- Jul 16, 2007
- Review
- 166 days
- Class
- Class II
- Product code
- GZJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K912178 (1991). 12 ancestors in all, the oldest K880042 (1988). 26 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK912178 Bio Tens 601, 606 and 608 (3000)Skylark Device Co., Ltd. · 1991
- 3 generations backK972244 NT2000Bio-Medical Research, Ltd. · 1998
- 2 generations backK990787 TRIO 300Ito Co., Ltd. · 1999
- 1 generation backK023231 Elfcare Device, Models 314A Through 314GMediseb, Ltd. · 2003
- This deviceK070299 Ezfit Digital Heating Tens (Model NO.: HR-661/UC-101)Ezfit Technology, Inc. · 2007
- Descendant · cites it directly · 25 of its ownK162517 Electronic Pulse Stimulator Model: PL-029K12 and PL-029K13Jkh Health Co., Ltd. · 2017
- Descendant · 2 generations on · 7 of its ownK182203 JKH Stimulator PlusJkh USA, LLC · 2019
- Descendant · 2 generations on · 4 of its ownK203574 HIVOX OTC Electrical Stimulator, EM59-l, HIVOX OTC Electrical…Hivox Biotek, Inc. · 2021
- Descendant · 3 generations on · 4 of its ownK191151 JKH Stimulator PlusJkh USA, LLC · 2019
- Descendant · 2 generations on · 3 of its ownK211403 HIVOX OTC Electrical Stimulator, FT610-BHivox Biotek, Inc. · 2021
Showing 5 of 26 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 26 · See all- K162517Electronic Pulse Stimulator Model: PL-029K12 and PL-029K13Jkh Health Co., Ltd. · 2017 · cites it directly25descendants
- K182203JKH Stimulator PlusJkh USA, LLC · 2019 · 2 generations on7descendants
- K203574HIVOX OTC Electrical Stimulator, EM59-l, HIVOX OTC Electrical Stimulator, EM59-2Hivox Biotek, Inc. · 2021 · 2 generations on4descendants
- K191151JKH Stimulator PlusJkh USA, LLC · 2019 · 3 generations on4descendants
- K211403HIVOX OTC Electrical Stimulator, FT610-BHivox Biotek, Inc. · 2021 · 2 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K912178 | Bio Tens 601, 606 and 608 (3000) | Skylark Device Co., Ltd. | 1991 | — |
| −3 | K972244 | NT2000 | Bio-Medical Research, Ltd. | 1998 | — |
| −2 | K990787 | TRIO 300 | Ito Co., Ltd. | 1999 | — |
| −1 | K023231 | Elfcare Device, Models 314A Through 314G | Mediseb, Ltd. | 2003 | — |
| 0 (this device) | K070299 | Ezfit Digital Heating Tens (Model NO.: HR-661/UC-101) | Ezfit Technology, Inc. | 2007 | — |
| +1 | K162517 | Electronic Pulse Stimulator Model: PL-029K12 and PL-029K13 | Jkh Health Co., Ltd. | 2017 | — |
| +2 | K182203 | JKH Stimulator Plus | Jkh USA, LLC | 2019 | — |
| +2 | K203574 | HIVOX OTC Electrical Stimulator, EM59-l, HIVOX OTC Electrical Stimulator, EM59-2 | Hivox Biotek, Inc. | 2021 | — |
| +3 | K191151 | JKH Stimulator Plus | Jkh USA, LLC | 2019 | — |
| +2 | K211403 | HIVOX OTC Electrical Stimulator, FT610-B | Hivox Biotek, Inc. | 2021 | — |
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 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2019 | 4 | 0 |
| 2020 | 4 | 0 |
| 2021 | 5 | 0 |
| 2022 | 3 | 0 |
| 2023 | 6 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 1 | 0 |
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K023231 | Elfcare Device, Models 314A Through 314GSummary page 1…Product Code: IRT Regulation Number: 21 CFR 890.5740 4. Predicate Device: The predicate device is the * ELFcare (K023231) , model no. :314A, 31483, 314C , marketed by Mediseb Ltd. * SHIAN JIA MEEI T… | 2003 |
| * | K052182 | Shian Jia Meei Two Channel Digital T.E.N.S.Summary page 3…and similar technological characteristics as the ELFcare (K023231), model no. : 314A, 314B, 314C, marketed by Mediseb Ltd. & SHIAN JIA MEEI TWO Channel Digital T.E.N.S (K052182) marketed by SHIAN JIA MEEI ENTERPRISE CO., LTD. Moreover, bench testing contained in this submission demonstrate that any differ… | 2005 |
What descends from it? (26)
See all 261 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K162517 | Electronic Pulse Stimulator Model: PL-029K12 and PL-029K13 | 2017 | 25 |
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 16 years and passes through 5 companies; a new generation was cleared every 4.3 years on median.
- None of the 12 ancestors has a recall.
- Of its descendants, K162517 (Jkh Health Co., Ltd., 2017) has gone furthest, with 25 descendants of its own.
- 2 other devices also cite its predicate K023231.
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. 2007, 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?
For Transcutaneous Electrical Nerve Stimulation, ezFit Digital Heating TENS (Model No.: HR-661/ UC-101) is intended for
* Symptomatic relief and management of chronic intractable pain.
For powered heating therapy, ezFit Digital Heating TENS (Model No.: HR-661/ UC-101) is intended for
sTemporary relief of minor aches and pains and muscle spasms
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K070299 · printed Nov 6, 2026
Cite this page
510(k) Report. “K070299: Ezfit Digital Heating Tens (Model NO.: HR-661/UC-101).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070299
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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