510(k) · Cleared
ClearedHANAROCare ReJu
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
M.I.Tech Co., Ltd. · NUH Stimulator, Nerve, Transcutaneous, Over-The-Counter
Cleared on Jul 27, 2016 as substantially equivalent to K122744 (Prospera Corporation, 2013) after a 118-day review. Its family tree reaches back 5 generations to 1994. 2 later devices descend from it.
- Decided
- Jul 27, 2016
- Review
- 118 days
- Class
- Class II
- Product code
- NUH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K940301 (1994). 9 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK940301 Compex 2Biodex Medical Systems, Inc. · 1994
- 4 generations backK011880 Compex SportCompex S.A. · 2002
- 3 generations backK060846 Therapeutic Massage CompanionEndurance Therapeutics · 2007
- 2 generations backK102598 HI-Dow-XPHi-Dow International, Inc. · 2011
- 1 generation backK122744 Prospera Otc Tens Electronic Pulse MassagerProspera Corporation · 2013
- This deviceK160893 HANAROCare ReJuM.I.Tech Co., Ltd. · 2016
- Descendant · cites it directly · 0 of its ownK200237 Transcutaneous Electronic Nerve StimulatorShenzhen Kentro Medical Electronics Co., Ltd. · 2020
- Descendant · cites it directly · 0 of its ownK170205 Low-Frequency Therapy Instrument /Model: KTR-201, KTR-202, KTR-203Shenzhen Kentro Medical Electronics Co., Ltd. · 2017
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K940301 | Compex 2 | Biodex Medical Systems, Inc. | 1994 | — |
| −4 | K011880 | Compex Sport | Compex S.A. | 2002 | — |
| −3 | K060846 | Therapeutic Massage Companion | Endurance Therapeutics | 2007 | — |
| −2 | K102598 | HI-Dow-XP | Hi-Dow International, Inc. | 2011 | — |
| −1 | K122744 | Prospera Otc Tens Electronic Pulse Massager | Prospera Corporation | 2013 | — |
| 0 (this device) | K160893 | HANAROCare ReJu | M.I.Tech Co., Ltd. | 2016 | — |
| +1 | K200237 | Transcutaneous Electronic Nerve Stimulator | Shenzhen Kentro Medical Electronics Co., Ltd. | 2020 | — |
| +1 | K170205 | Low-Frequency Therapy Instrument /Model: KTR-201, KTR-202, KTR-203 | Shenzhen Kentro Medical Electronics Co., Ltd. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2020 | 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 |
|---|---|---|---|
| * | K122744 | Prospera Otc Tens Electronic Pulse MassagerSummary page 5…household work activities. 9. Predicate Device: • Primary Predicate Device: Prospera OTC TENS Electronic Pulse Massager(model: PL029) by Prospera Corporation (K122744) • Reference Predicate Device: - HIVOX Electric Stimulator OTC TENS, Rapid Relief by HIVOX BIOTEK INC (K140650)… | 2013 |
| † | K140650 | Hivox Electric Stimulator Otc Tens | 2014 |
| † | K140168 | Easystim TN28_Otc | 2014 |
| † | K141260 | Electronic Pulse Stimulator | 2014 |
What descends from it? (2)
2 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 22 years and passes through 6 companies; a new generation was cleared every 3.4 years on median.
- None of the 9 ancestors has a recall.
- Of its descendants, K200237 (Shenzhen Kentro Medical Electronics Co., Ltd., 2020) has gone furthest, with 0 descendants of its own.
- 7 other devices also cite its predicate K122744.
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. 2016, 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?
HANAROCare ReJu is indicated for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm) and lower extremities (leg) due to strain from exercise or normal household work activities.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K160893 · printed Nov 5, 2026
Cite this page
510(k) Report. “K160893: HANAROCare ReJu.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K160893
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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