# K112415: Lifecare Arm & Leg Pain Relief System

- Pathway: 510(k) (Traditional)
- Applicant: Everyway Medical Instruments Co.,Ltd
- Decided: Oct 21, 2011 after 60 days
- Product code: NUH (Stimulator, Nerve, Transcutaneous, Over-The-Counter)
- Device class: 2
- Regulation: 21 CFR 882.5890
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K940301 (1994). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033122: 5000Z System (Otc), Prizm Medical, Inc. (2004) Summary page 1.
- K091757: Otc Tens for Arm and Leg Pain Relief, Model WL-2407, Well-Life Healthcare Limited (2010) Summary page 1.

## Indications for use
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

Source page: https://510kreport.com/device/K112415
Methodology: https://510kreport.com/methodology