# K102786: Well-Life Otc Ems System

- Pathway: 510(k) (Traditional)
- Applicant: Well-Life Healthcare Limited
- Decided: Jul 1, 2011 after 277 days
- Product code: NGX (Stimulator, Muscle, Powered, For Muscle Conditioning)
- Device class: 2
- Regulation: 21 CFR 890.5850
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K940301 (1994). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071666: Slendertone Enervive, Model 561, Bio-Medical Research Corp. (2008) Summary page 1.
- K000947: Ultrastim Electrode, Model US4040, Axelgaard Mfg. Co., Ltd. (2000) Summary page 1.

## Indications for use
The Well-Life OTO EMS System / model no. WL-2412(A) is intended for use by healthy adults for the stimulation of healthy muscles in order to improve or facilitate muscle performance.

Source page: https://510kreport.com/device/K102786
Methodology: https://510kreport.com/methodology