510(k) · Cleared
ClearedHeat StimPlus
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Famidoc Technology Co., Ltd. · NUH Stimulator, Nerve, Transcutaneous, Over-The-Counter
Cleared on Dec 13, 2021 as substantially equivalent to K203574 (Hivox Biotek, Inc., 2021) after a 90-day review. Its family tree reaches back 9 generations to 1994.
- Decided
- Dec 13, 2021
- Review
- 90 days
- Class
- Class II
- Product code
- NUH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K940301 (1994). 27 ancestors in all, the oldest K880042 (1988). No later device cites it as a predicate yet.
- Root · 9 generations backK940301 Compex 2Biodex Medical Systems, Inc. · 1994
- 5 generations between
- 3 generations backK171803 HIVOX OTC Electrical StimulatorHivox Biotek, Inc. · 2017
- 2 generations backK190347 HIVOX OTC Electrical StimulatorHivox Biotek, Inc. · 2019
- 1 generation backK203574 HIVOX OTC Electrical Stimulator, EM59-l, HIVOX OTC Electrical…Hivox Biotek, Inc. · 2021
- This deviceK212918 Heat StimPlusFamidoc Technology Co., Ltd. · 2021
Show all 9 generations
- Root · 9 generations backK940301 Compex 2Biodex Medical Systems, Inc. · 1994
- 8 generations backK011880 Compex SportCompex S.A. · 2002
- 7 generations backK060846 Therapeutic Massage CompanionEndurance Therapeutics · 2007
- 6 generations backK110068 Model PM3030Omron Healthcare, Inc. · 2011
- 5 generations backK132993 Counter Otc Tens DeviceCounter Scientific Development (Gz), Ltd. · 2014
- 4 generations backK150386 Tyece OTC TENS DeviceTyece, Ltd. · 2015
- 3 generations backK171803 HIVOX OTC Electrical StimulatorHivox Biotek, Inc. · 2017
- 2 generations backK190347 HIVOX OTC Electrical StimulatorHivox Biotek, Inc. · 2019
- 1 generation backK203574 HIVOX OTC Electrical Stimulator, EM59-l, HIVOX OTC Electrical…Hivox Biotek, Inc. · 2021
- This deviceK212918 Heat StimPlusFamidoc Technology Co., Ltd. · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K940301 | Compex 2 | Biodex Medical Systems, Inc. | 1994 | — |
| −8 | K011880 | Compex Sport | Compex S.A. | 2002 | — |
| −7 | K060846 | Therapeutic Massage Companion | Endurance Therapeutics | 2007 | — |
| −6 | K110068 | Model PM3030 | Omron Healthcare, Inc. | 2011 | — |
| −5 | K132993 | Counter Otc Tens Device | Counter Scientific Development (Gz), Ltd. | 2014 | — |
| −4 | K150386 | Tyece OTC TENS Device | Tyece, Ltd. | 2015 | — |
| −3 | K171803 | HIVOX OTC Electrical Stimulator | Hivox Biotek, Inc. | 2017 | — |
| −2 | K190347 | HIVOX OTC Electrical Stimulator | Hivox Biotek, Inc. | 2019 | — |
| −1 | K203574 | HIVOX OTC Electrical Stimulator, EM59-l, HIVOX OTC Electrical Stimulator, EM59-2 | Hivox Biotek, Inc. | 2021 | — |
| 0 (this device) | K212918 | Heat StimPlus | Famidoc Technology Co., Ltd. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1991 | 2 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2007 | 1 | 0 |
| 2013 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 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 NUH? 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 NUH device
- #1 K190783 Health Expert Electronic Stimulator (model…score 15.8 · 7 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K203574 | HIVOX OTC Electrical Stimulator, EM59-l, HIVOX OTC Electrical Stimulator, EM59-2Summary page 5…Version:1.1 3. Predicate Device: 510(K) Trade or Proprietary or Model Name Manufacturer K203574 HIVOX OTC Electrical Stimulator EM59-2 HIVOX BIOTEK INC. 4. Description of Proposed Device: The Heat S… | 2021 |
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?
- The line of descent spans 27 years and passes through 8 companies; a new generation was cleared every 2.1 years on median.
- None of the 27 ancestors has a recall.
- 3 other devices also cite its predicate K203574.
How does its category compare?
All NUH devicesNUH Stimulator, Nerve, Transcutaneous, Over-The-Counter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · NUH
15in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NUH
119in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NUH
No recall names NUH since 2007.
Adverse event reports per year · NUH
7in 2025
MAUDE reports naming product code NUH, 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 | 4 | 161 | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 3 | 148 | 0 | 0 |
| 2011 | 6 | 231 | 0 | 0 |
| 2012 | 6 | 170 | 0 | 0 |
| 2013 | 10 | 189 | 0 | 1 |
| 2014 | 16 | 212 | 0 | 9 |
| 2015 | 14 | 198 | 0 | 11 |
| 2016 | 13 | 145 | 0 | 13 |
| 2017 | 17 | 155 | 0 | 21 |
| 2018 | 16 | 121 | 0 | 18 |
| 2019 | 19 | 213 | 0 | 5 |
| 2020 | 14 | 147 | 0 | 8 |
| 2021 | 14 | 198 | 0 | 7 |
| 2022 | 20 | 103 | 0 | 2 |
| 2023 | 15 | 127 | 0 | 4 |
| 2024 | 20 | 90 | 0 | 7 |
| 2025 | 15 | 119 | 0 | 7 |
| 2026 | 5 | 137 | 0 | — |
What is it indicated for?
The Heat StimPlus, Model FDES115 is intended
TENS: This function is designated to be used for temporary relief of pain associated with sore and aching muscles in the
shoulder, waist, back, upper extremities (arn) and lower extremities (leg)due to strain from exercise or normal household
work activities.
EMS: This function is designed to be used for stimulating healthy muscles in order to improve and facilitate muscle
performance.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K212918 · printed Nov 6, 2026
Cite this page
510(k) Report. “K212918: Heat StimPlus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K212918
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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