# K162663: WELL LIFE Rx Wireless TENS/EMS Stimulator, model WR-2603/2603A, WR-2604/2604A and WR-2605/2605A

- Pathway: 510(k) (Traditional)
- Applicant: Well-Life Healthcare Limited
- Decided: Jan 17, 2017 after 113 days
- Product code: GZJ (Stimulator, Nerve, Transcutaneous, For Pain Relief)
- 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
Transcutaneous Electrical Nerve Stimulator (TENS) can be used for the following applications (Available for WR-2603/2603A, and TENS function of WR-2605/ 2605A): • For symptomatic relief of chronic intractable pain Electrical Muscle Stimulation (EMS) on can be used for the following applications (Available for WR-2604/2604A, and EMS function of WR-2605/ 2605A): • Relax muscle spasms • Prevent or retard disuse atrophy • Increase local blood circulation • Re-educate muscles • Maintain or increase the range of motion

Source page: https://510kreport.com/device/K162663
Methodology: https://510kreport.com/methodology