510(k) · Cleared
ClearedModels Tens 7000, Ems 7500 and Twin Stim
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Koalaty Products, Inc. · IPF Stimulator, Muscle, Powered
Cleared on Mar 24, 2008 as substantially equivalent to K020749 (Everyway Medical Instruments Co.,Ltd, 2002) and 1 other predicate after a 14-day review. Its family tree reaches back 3 generations to 2001. 2 later devices descend from it.
- Decided
- Mar 24, 2008
- Review
- 14 days
- Class
- Class II
- Product code
- IPF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K010782 (2001). 5 ancestors in all, the oldest K010665 (2001). 2 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK010782 Transamerican TensTransamerica Medical Systems · 2001
- 2 generations backK020749 Digital Transcutaneous Electrical Nerve Stimulator, Model EV-803…Everyway Medical Instruments Co.,Ltd · 2002
- 1 generation backK071951 Comfy Series: EV-804, EV-805 & EV-806Everyway Medical Instruments Co.,Ltd · 2007
- This deviceK080661 Models Tens 7000, Ems 7500 and Twin StimKoalaty Products, Inc. · 2008
- Descendant · cites it directly · 1 of its ownK123642 Muscle Stimulation SystemNiveus Medical, Inc. · 2013
- Descendant · 2 generations on · 0 of its ownK150742 Muscle Stimulation System 110Niveus Medical, Inc. · 2015
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 |
|---|---|---|---|---|---|
| −3 | K010782 | Transamerican Tens | Transamerica Medical Systems | 2001 | — |
| −2 | K020749 | Digital Transcutaneous Electrical Nerve Stimulator, Model EV-803 Digital Tens | Everyway Medical Instruments Co.,Ltd | 2002 | — |
| −1 | K071951 | Comfy Series: EV-804, EV-805 & EV-806 | Everyway Medical Instruments Co.,Ltd | 2007 | — |
| 0 (this device) | K080661 | Models Tens 7000, Ems 7500 and Twin Stim | Koalaty Products, Inc. | 2008 | — |
| +1 | K123642 | Muscle Stimulation System | Niveus Medical, Inc. | 2013 | — |
| +2 | K150742 | Muscle Stimulation System 110 | Niveus Medical, Inc. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2015 | 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 IPF? 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 IPF device
- #1 K241433 EVE Synergy (EVE-20M)score 19.6 · 25 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 |
|---|---|---|---|
| * | K020749 | Digital Transcutaneous Electrical Nerve Stimulator, Model EV-803 Digital TensSummary page 1…5-Substantial Equivalency is claimed against the following device: Models EV-804, EV-805 and EV-806 from Everyway Medical Instruments Co., Ltd. 510k# K020749, 510k #K071951 16-Description of the Device: This series, which includes models TENS 7000, EMS 7500, and TWIN STIM, are Transc… | 2002 |
| * | K071951 | Comfy Series: EV-804, EV-805 & EV-806Summary page 1…quivalency is claimed against the following device: Models EV-804, EV-805 and EV-806 from Everyway Medical Instruments Co., Ltd. 510k# K020749, 510k #K071951 16-Description of the Device: This series, which includes models TENS 7000, EMS 7500, and TWIN STIM, are Transcutaneous Electr… | 2007 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K123642 | Muscle Stimulation System | 2013 | 1 |
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 7 years and passes through 3 companies; a new generation was cleared every 1.5 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K123642 (Niveus Medical, Inc., 2013) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K020749.
How does its category compare?
All IPF devicesIPF Stimulator, Muscle, Powered: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · IPF
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IPF
257in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IPF
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IPF
8in 2025
MAUDE reports naming product code IPF, 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 | 8 | 143 | 0 | 11 |
| 2008 | 6 | 140 | 1 | 213 |
| 2009 | 7 | 216 | 0 | 150 |
| 2010 | 4 | 121 | 0 | 14 |
| 2011 | 4 | 275 | 1 | 25 |
| 2012 | 4 | 269 | 3 | 16 |
| 2013 | 10 | 180 | 0 | 6 |
| 2014 | 4 | 264 | 0 | 19 |
| 2015 | 3 | 43 | 0 | 11 |
| 2016 | 7 | 113 | 0 | 8 |
| 2017 | 5 | 110 | 0 | 2 |
| 2018 | 5 | 73 | 0 | 3 |
| 2019 | 4 | 133 | 0 | 10 |
| 2020 | 9 | 121 | 0 | 13 |
| 2021 | 15 | 98 | 0 | 3 |
| 2022 | 7 | 108 | 0 | 4 |
| 2023 | 9 | 255 | 1 | 8 |
| 2024 | 7 | 201 | 0 | 5 |
| 2025 | 3 | 257 | 0 | 8 |
| 2026 | 3 | 206 | 0 | — |
What is it indicated for?
APPLICABLE FOR TENS 7000 AND TWIN STIM: This device is an electrical nerve stimulator indicated for use for pain relief by applying an electrical current to electrodes on a patient's skin to treat pain. In particular, this device is indicated for use for (1) Symptomatic relief and management of chronic (long term) intractable pain and (2) adjunctive treatment in the management of post surgical and post traumatic pain problems APPLICABLE FOR EMS 7500 and…
Read the full statement (151 words)
APPLICABLE FOR TENS 7000 AND TWIN STIM:
This device is an electrical nerve stimulator indicated for use for pain relief by applying an electrical current to electrodes on a patient's skin to treat pain. In particular, this device is indicated for use for (1) Symptomatic relief and management of chronic (long term) intractable pain and (2) adjunctive treatment in the management of post surgical and post traumatic pain problems
APPLICABLE FOR EMS 7500 and TWIN STIM:
This device is an electrically powered muscle stimulator indicated for use for medical purposes to repeatedly contract muscles by passing electrical currents through electrodes contacting the affected body area. In particular, this device is indicated for use for (1) Relaxing muscle spasms, (2) Increasing local blood circulation, (3) Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis, (4) Muscle re-education, (5) Maintaining or increasing range of motion, and (6) Preventing or retarding disuse atrophy
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080661 · printed Nov 6, 2026
Cite this page
510(k) Report. “K080661: Models Tens 7000, Ems 7500 and Twin Stim.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K080661
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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