510(k) · Cleared
ClearedElectrical Muscle Stimulator, Models N605 and N607
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Everyway Medical Instruments Co.,Ltd · IPF Stimulator, Muscle, Powered
Cleared on Dec 10, 2003 as substantially equivalent to K020750 (Everyway Medical Instruments Co.,Ltd, 2002) after a 30-day review. Its family tree reaches back 2 generations to 2001. 2 later devices descend from it.
- Decided
- Dec 10, 2003
- Review
- 30 days
- Class
- Class II
- Product code
- IPF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K010665 (2001). 2 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK010665 Transamerica Digital EmsTransamerica Medical Systems · 2001
- 1 generation backK020750 Digital Electrical Muscle Stimulator, Model EV-807 Digital EmsEveryway Medical Instruments Co.,Ltd · 2002
- This deviceK033544 Electrical Muscle Stimulator, Models N605 and N607Everyway Medical Instruments Co.,Ltd · 2003
- Descendant · cites it directly · 1 of its ownK072795 Models Ems 5.0, Ems 5.1Koalaty Products, Inc. · 2007
- Descendant · 2 generations on · 0 of its ownK091248 Maxems, Models 1000 and 2000Bio Protech, Inc. · 2009
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 |
|---|---|---|---|---|---|
| −2 | K010665 | Transamerica Digital Ems | Transamerica Medical Systems | 2001 | — |
| −1 | K020750 | Digital Electrical Muscle Stimulator, Model EV-807 Digital Ems | Everyway Medical Instruments Co.,Ltd | 2002 | — |
| 0 (this device) | K033544 | Electrical Muscle Stimulator, Models N605 and N607 | Everyway Medical Instruments Co.,Ltd | 2003 | — |
| +1 | K072795 | Models Ems 5.0, Ems 5.1 | Koalaty Products, Inc. | 2007 | — |
| +2 | K091248 | Maxems, Models 1000 and 2000 | Bio Protech, Inc. | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2009 | 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 19.7 · 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? (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 |
|---|---|---|---|
| * | K020750 | Digital Electrical Muscle Stimulator, Model EV-807 Digital EmsSummary page 1…15-Substantial Equivalency is claimed against the following device: Digital EMS, model EV-807 from Everyway Medical Instruments Co., Ltd. 510k# K020750 16-Description of the Device: The Special 510(k) premarket notification describes a modification to Everyway's currently lega… | 2002 |
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 |
|---|---|---|---|
| K072795 | Models Ems 5.0, Ems 5.1 | 2007 | 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 2 years and passes through 2 companies; a new generation was cleared every 1.5 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K072795 (Koalaty Products, Inc., 2007) has gone furthest, with 1 descendant of its own.
- 3 other devices also cite its predicate K020750.
How does its category compare?
All IPF devicesIPF Stimulator, Muscle, Powered: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
Electrical Muscle Stimulator Series (Model Numbers N605, N607) is an electrically powered muscle stimulator intended 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:
- Relaxing muscle spasms
- Increasing local blood circulation.
- Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis.
- Muscle re-education.
- Maintaining or increasing range of motion
- Preventing or retarding disuse atrophy
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033544 · printed Nov 5, 2026
Cite this page
510(k) Report. “K033544: Electrical Muscle Stimulator, Models N605 and N607.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K033544
Report an extraction error
Are you the manufacturer?
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