510(k) · Cleared
ClearedLow-frequency Multi-function physiotherapy instrument
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shenzhen Kentro Medical Electronics Co., Ltd. · NUH Stimulator, Nerve, Transcutaneous, Over-The-Counter
Cleared on Mar 25, 2021 as substantially equivalent to K191982 (Shenzhen Kentro Medical Electronics Co., Ltd., 2020) after a 426-day review. Its family tree reaches back 7 generations to 1994.
- Decided
- Mar 25, 2021
- Review
- 426 days
- Class
- Class II
- Product code
- NUH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K940301 (1994). 12 ancestors in all. No later device cites it as a predicate yet.
- Root · 7 generations backK940301 Compex 2Biodex Medical Systems, Inc. · 1994
- 6 generations backK011880 Compex SportCompex S.A. · 2002
- 5 generations backK060846 Therapeutic Massage CompanionEndurance Therapeutics · 2007
- 4 generations backK102598 HI-Dow-XPHi-Dow International, Inc. · 2011
- 3 generations backK122744 Prospera Otc Tens Electronic Pulse MassagerProspera Corporation · 2013
- 2 generations backK133929 Health Expert Elctronic StimulatorShenzhen Osto Technology Company Limited · 2014
- 1 generation backK191982 Low-Frequency Multi-function Physiotherapy Instrument (Model…Shenzhen Kentro Medical Electronics Co., Ltd. · 2020
- This deviceK200177 Low-frequency Multi-function physiotherapy instrumentShenzhen Kentro Medical Electronics Co., Ltd. · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K940301 | Compex 2 | Biodex Medical Systems, Inc. | 1994 | — |
| −6 | K011880 | Compex Sport | Compex S.A. | 2002 | — |
| −5 | K060846 | Therapeutic Massage Companion | Endurance Therapeutics | 2007 | — |
| −4 | K102598 | HI-Dow-XP | Hi-Dow International, Inc. | 2011 | — |
| −3 | K122744 | Prospera Otc Tens Electronic Pulse Massager | Prospera Corporation | 2013 | — |
| −2 | K133929 | Health Expert Elctronic Stimulator | Shenzhen Osto Technology Company Limited | 2014 | — |
| −1 | K191982 | Low-Frequency Multi-function Physiotherapy Instrument (Model: KTR-2230… | Shenzhen Kentro Medical Electronics Co., Ltd. | 2020 | — |
| 0 (this device) | K200177 | Low-frequency Multi-function physiotherapy instrument | Shenzhen Kentro Medical Electronics Co., Ltd. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 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 |
|---|---|---|---|
| * | K191982 | Low-Frequency Multi-function Physiotherapy Instrument (Model: KTR-2230, KTR-2220… Cleared while this submission was under review Summary page 4…IIA, P.T.S-IIB, CP-I 2222, KTR2212 302, AST-303 510(k) Number K191982 K163611 K182136 Product Code NUH, NGX NUH, NGX, NYN… | 2020 |
| † | K163611 | Pain Therapy Device | 2017 |
| † | K182136 | Intelligent Wireless Fitness Apparatus (Model: AST-301, AST-302, AST-303) | 2019 |
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 7 companies; a new generation was cleared every 3.4 years on median.
- None of the 12 ancestors has a recall.
- 1 other device also cites its predicate K191982.
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?
KTR-2240,KTR-2250,KTR-2610,KTR-2640,KTR-2650: (TENS, EMS, FITNESS) TENS (Mode1~20): To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, back of the neck, arm, leg, and foot due to strain from exercise or normal household work activities by applying current to stimulate nerve. EMS (Mode 21~40): It is intended to stimulate healthy muscles in order to improve and facilitate muscle performance.…
Read the full statement (130 words)
KTR-2240,KTR-2250,KTR-2610,KTR-2640,KTR-2650: (TENS, EMS, FITNESS)
TENS (Mode1~20): To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, back of the neck, arm, leg, and foot due to strain from exercise or normal household work activities by applying current to stimulate nerve.
EMS (Mode 21~40): It is intended to stimulate healthy muscles in order to improve and facilitate muscle performance.
FITNESS (Mode 41~50): Improvement of abdominal tone, strengthening of the abdominal muscle development of firmer abdomen.
KTR-2241,KTR-2251,KTR-2242,KTR-2252, KTR-2611,KTR-2641,KTR-2651,KTR-2612,KTR-2642, KTR-2652: (TENS)
To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, back of the neck, arm, leg, and foot due to strain from exercise or normal household work activities by applying current to stimulate nerve.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K200177 · printed Nov 6, 2026
Cite this page
510(k) Report. “K200177: Low-frequency Multi-function physiotherapy instrument.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K200177
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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