510(k) · Cleared
ClearedLifecare Arm & Leg 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 21, 2011 as substantially equivalent to K033122 (Prizm Medical, Inc., 2004) and 1 other predicate after a 60-day review. Its family tree reaches back 4 generations to 1994.
- Decided
- Oct 21, 2011
- Review
- 60 days
- Class
- Class II
- Product code
- NUH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K940301 (1994). 6 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK940301 Compex 2Biodex Medical Systems, Inc. · 1994
- 3 generations backK011880 Compex SportCompex S.A. · 2002
- 2 generations backK060846 Therapeutic Massage CompanionEndurance Therapeutics · 2007
- 1 generation backK091757 Otc Tens for Arm and Leg Pain Relief, Model WL-2407Well-Life Healthcare Limited · 2010
- This deviceK112415 Lifecare Arm & Leg 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 |
|---|---|---|---|---|---|
| −4 | K940301 | Compex 2 | Biodex Medical Systems, Inc. | 1994 | — |
| −3 | K011880 | Compex Sport | Compex S.A. | 2002 | — |
| −2 | K060846 | Therapeutic Massage Companion | Endurance Therapeutics | 2007 | — |
| −1 | K091757 | Otc Tens for Arm and Leg Pain Relief, Model WL-2407 | Well-Life Healthcare Limited | 2010 | — |
| 0 (this device) | K112415 | Lifecare Arm & Leg Pain Relief System | Everyway Medical Instruments Co.,Ltd | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2005 | 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? (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 |
|---|---|---|---|
| * | K033122 | 5000Z System (Otc)Summary page 1…e of the Device: LIFECARE Arm & Leg Pain Relief System, model EV7820. 3. Information of the 510(k) Cleared Device (Predicate Device): - The Prizm 5000-Z System (K033122) - Well-Life OTC TENS, for Arm & Leg Pain Relief, model WL-2407(K091757) 4. Classification Information: Trade/Device Nam… | 2004 |
| * | K091757 | Otc Tens for Arm and Leg Pain Relief, Model WL-2407Summary page 1…Information of the 510(k) Cleared Device (Predicate Device): - The Prizm 5000-Z System (K033122) - Well-Life OTC TENS, for Arm & Leg Pain Relief, model WL-2407(K091757) 4. Classification Information: Trade/Device Name: LIFECARE Arm & Leg Pain Relief System, model EV-820. Regulation Number:… | 2010 |
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 17 years and passes through 5 companies; a new generation was cleared every 5.6 years on median.
- None of the 6 ancestors has a recall.
- 6 other devices also cite its predicate K033122.
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 LIFECARE Arm & Leg Pain Relief System, model EV-820 is intended for temporary relief of pain associated with sore and aching muscles in the upper and lower extremities (arm and/or leg) due to strain from exercise or normal household and work activities
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K112415 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112415: Lifecare Arm & Leg Pain Relief System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112415
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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