510(k) · Cleared
ClearedManaFlexx 2 (model: MF002-RX, MF002-OTC)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Manamed, Inc. · NUH Stimulator, Nerve, Transcutaneous, Over-The-Counter
Cleared on Nov 3, 2023 as substantially equivalent to K191151 (Jkh USA, LLC, 2019) after a 156-day review. Its family tree reaches back 9 generations to 1988. 1 later device descends from it.
- Decided
- Nov 3, 2023
- Review
- 156 days
- Class
- Class II
- Product code
- NUH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K881114 (1988). 51 ancestors in all, the oldest K872976 (1987). 1 later device descends from it, 1 citing it directly.
- Root · 9 generations backK881114 Empi Model 989, TensEmpi · 1988
- 5 generations between
- 3 generations backK140333 AscendNeurometrix, Inc. · 2014
- 2 generations backK182203 JKH Stimulator PlusJkh USA, LLC · 2019
- 1 generation backK191151 JKH Stimulator PlusJkh USA, LLC · 2019
- This deviceK231569 ManaFlexx 2 (model: MF002-RX, MF002-OTC)Manamed, Inc. · 2023
- Descendant · cites it directly · 0 of its ownK243613 Patch-TEA (Model TRI-21)Transtimulation Research, Inc. · 2025
Show all 9 generations
- Root · 9 generations backK881114 Empi Model 989, TensEmpi · 1988
- 8 generations backK970203 Epix VTEmpi · 1997
- 7 generations backK061650 Select Tens, Model 4600SEmpi · 2007
- 6 generations backK090922 Empi Active Transcutaneous Nerve StimulatorEmpi · 2009
- 5 generations backK121184 SensusNeurometrix, Inc. · 2012
- 4 generations backK130919 SensusNeurometrix, Inc. · 2013
- 3 generations backK140333 AscendNeurometrix, Inc. · 2014
- 2 generations backK182203 JKH Stimulator PlusJkh USA, LLC · 2019
- 1 generation backK191151 JKH Stimulator PlusJkh USA, LLC · 2019
- This deviceK231569 ManaFlexx 2 (model: MF002-RX, MF002-OTC)Manamed, Inc. · 2023
Most influential descendants
Showing 1 of 1 · See all- K243613Patch-TEA (Model TRI-21)Transtimulation Research, Inc. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K881114 | Empi Model 989, Tens | Empi | 1988 | — |
| −8 | K970203 | Epix VT | Empi | 1997 | — |
| −7 | K061650 | Select Tens, Model 4600S | Empi | 2007 | — |
| −6 | K090922 | Empi Active Transcutaneous Nerve Stimulator | Empi | 2009 | — |
| −5 | K121184 | Sensus | Neurometrix, Inc. | 2012 | — |
| −4 | K130919 | Sensus | Neurometrix, Inc. | 2013 | — |
| −3 | K140333 | Ascend | Neurometrix, Inc. | 2014 | — |
| −2 | K182203 | JKH Stimulator Plus | Jkh USA, LLC | 2019 | — |
| −1 | K191151 | JKH Stimulator Plus | Jkh USA, LLC | 2019 | — |
| 0 (this device) | K231569 | ManaFlexx 2 (model: MF002-RX, MF002-OTC) | Manamed, Inc. | 2023 | — |
| +1 | K243613 | Patch-TEA (Model TRI-21) | Transtimulation Research, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1988 | 2 | 0 |
| 1991 | 2 | 0 |
| 1992 | 2 | 0 |
| 1993 | 2 | 0 |
| 1994 | 2 | 0 |
| 1995 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 2 | 0 |
| 1998 | 3 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2002 | 2 | 0 |
| 2003 | 3 | 0 |
| 2004 | 1 | 0 |
| 2005 | 3 | 0 |
| 2007 | 3 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 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 |
|---|---|---|---|
| * | K191151 | JKH Stimulator PlusSummary page 7…4. Predicate Device Information Predicate Device1 (Primary): Report by ManaMed Inc Page 1 of 13 510(K) Number: K191151 Company Name: JKH USA, LLC Address: 1142 S. Diamond Bar Blvd, #861, Diamond Bar, CA 91765 Trade Name: JKH Stimulator Plus Model:… | 2019 |
| † | K200237 | Transcutaneous Electronic Nerve Stimulator | 2020 |
| † | K183154 | SM Electrodes | 2019 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K243613 | Patch-TEA (Model TRI-21) | 2025 | 0 |
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 35 years and passes through 4 companies; a new generation was cleared every 3.2 years on median.
- 1 of the 51 ancestors has a recall of any class.
- Of its descendants, K243613 (Transtimulation Research, Inc., 2025) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K191151.
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. 2023, 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?
For Over-The-Counter Use: TENS: ManaFlexx 2 (MF002-OTC) is used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, arm, and leg, due to strain from exercise or normal household and work activities. ManaFlexx 2 (MF002-OTC) is also intended for symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis. PMS/NMES: ManaFlexx2 (MF002-OTC) is used to stimulate…
Read the full statement (226 words)
For Over-The-Counter Use:
TENS:
ManaFlexx 2 (MF002-OTC) is used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, arm, and leg, due to strain from exercise or normal household and work activities.
ManaFlexx 2 (MF002-OTC) is also intended for symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis.
PMS/NMES:
ManaFlexx2 (MF002-OTC) is used to stimulate healthy muscles in order to improve and facilitate muscle performance. To be used for the improvement of muscle tone and firmness, and for strengthening muscles in the arms, abdomen, legs, and buttocks. Not intended for use in any therapy or for the treatment of any medical conditions or diseases.
ManaFlexx2 (MF002-OTC) is also intended to temporarily increase local blood circulation in the healthy muscles of lower extremities.
For Prescription Use:
TENS:
ManaFlexx2 (MF002-RX) is intended for the following use:
- Symptomatic relief and management of chronic, intractable pain
- Adjunctive treatment for post-surgical and post-trauma acute pain
- Relief of pain associated with arthritis
PMS/NMES:
ManaFlexx2 (MF002-RX) is intended for the following use:
- Temporary relaxation of muscle spasm
- Prevention or retardation of disuse atrophy
- Muscle re-education
- Maintaining or increasing range of motion
- Increase of local blood flow in the treatment area
- Prevention of post-surgical venous thrombosis through immediate stimulation of calf muscles
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K231569 · printed Nov 6, 2026
Cite this page
510(k) Report. “K231569: ManaFlexx 2 (model: MF002-RX, MF002-OTC).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K231569
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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