# K150681: Gemore Otc Tens

- Pathway: 510(k) (Traditional)
- Applicant: Gemore Technology Co, Ltd.
- Decided: May 12, 2015 after 56 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: 6 generations back to K945676 (1995). 19 ancestors in all.
No later device cites it as a predicate yet.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133723: Otc Patch, Well-Life Healthcare Limited (2014) Summary page 4.
- K091757: Otc Tens for Arm and Leg Pain Relief, Model WL-2407, Well-Life Healthcare Limited (2010) Summary page 4.

## Indications for use
The Gemore OTC TENS, Model GM310PP/GM320PP/GM321PP/GM330PP, is intended for temporary relief of pain associated with sore and aching muscles in the low back as well as 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/K150681
Methodology: https://510kreport.com/methodology