510(k) · Cleared
ClearedEveryway Low Back Pain Relief System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Everyway Medical Instruments Co.,Ltd · NUH Stimulator, Nerve, Transcutaneous, Over-The-Counter
Cleared on Oct 18, 2011 as substantially equivalent to K060222 (Gemore Technology Co, Ltd., 2006) after a 217-day review. Its family tree reaches back 2 generations to 2004.
- Decided
- Oct 18, 2011
- Review
- 217 days
- Class
- Class II
- Product code
- NUH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K040512 (2004). No later device cites it as a predicate yet.
- Root · 2 generations backK040512 Limited Function WL/Otc-Tens Device, Model WL-2103A, WL-2203A…Well-Life Healthcare, Inc. · 2004
- 1 generation backK060222 Low Back Pain Relief System /Models GM310PP,GM320PP,GM321PP, and…Gemore Technology Co, Ltd. · 2006
- This deviceK110716 Everyway Low Back Pain Relief SystemEveryway Medical Instruments Co.,Ltd · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K040512 | Limited Function WL/Otc-Tens Device, Model WL-2103A, WL-2203A, WL-2203B and… | Well-Life Healthcare, Inc. | 2004 | — |
| −1 | K060222 | Low Back Pain Relief System /Models GM310PP,GM320PP,GM321PP, and GM330PP | Gemore Technology Co, Ltd. | 2006 | — |
| 0 (this device) | K110716 | Everyway Low Back Pain Relief System | Everyway Medical Instruments Co.,Ltd | 2011 | — |
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 |
|---|---|---|---|
| * | K060222 | Low Back Pain Relief System /Models GM310PP,GM320PP,GM321PP, and GM330PPSummary page 1…veryway Low Back Pain Relief System, model EV-820. 3. Information of the 510(k) Cleared Device (Predicate Device): Gemore Low Back Pain Relief System, model GM31OPP(K060222). 4. Classification Information: Trade/Device Name: Everyway Low Back Pain Relief System, model EV-820. Regulation Number… | 2006 |
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 7 years and passes through 3 companies; a new generation was cleared every 5.5 years on median.
- None of the 2 ancestors has a recall.
- 2 other devices also cite its predicate K060222.
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. 2011, 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?
The Everyway Low Back Pain Relief System, model EV-820 is indicated for over the counter use in the temporary relief of pain associated with sore and aching muscles in the low back due to strain from exercise or normal household and work activities
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K110716 · printed Nov 5, 2026
Cite this page
510(k) Report. “K110716: Everyway Low Back Pain Relief System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K110716
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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