# K213091: Well-Life TENS/EMS/Heating Stimulator

- Pathway: 510(k) (Traditional)
- Applicant: Well-Life Healthcare Limited
- Decided: Feb 19, 2022 after 148 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: 9 generations back to K940301 (1994). 28 ancestors in all.
No later device cites it as a predicate yet.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K203574: HIVOX OTC Electrical Stimulator, EM59-l, HIVOX OTC Electrical Stimulator, EM59-2, Hivox Biotek, Inc. (2021) Summary page 6.
- K172809: OTC Combo TENS/EMS System, Well-Life Healthcare Limited (2017) Summary page 6.

## Indications for use
The WL-2405K+ is a digital electrical and heat stimulator for active treatment application as the following: TENS can be used for the following applications: - For temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities (arm) and lower extremities (leg) due to strain from exercise or normal household and work activities. EMS can be used for the following applications: - For healthy adults for the stimulation of healthy muscles in order to improve or facilitate muscle performance. Heat Mode: - Heat can be used for temporary relief of minor aches and pains.

Source page: https://510kreport.com/device/K213091
Methodology: https://510kreport.com/methodology