# K120569: Gemore Tens System

- Pathway: 510(k) (Abbreviated)
- Applicant: Gemore Technology Co, Ltd.
- Decided: Jul 20, 2012 after 144 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
Longest line of descent: 3 generations back to K881114 (1988). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061650: Select Tens, Model 4600S, Empi (2007) Summary page 1.

## Indications for use
The GEMORE TENS System, model GM31OTP/GM32OTP/ GM33OTP/GM34OTP Transcutaneous Electrical Nerve Stimulators are indicated for: * symptomatic relief of chronic, intractable pain * adjunctive treatment for post-surgical and post-traumatic acute pain * relief of pain associated with osteoarthritis of the knee and rheumatoid arthritis of the hand

Source page: https://510kreport.com/device/K120569
Methodology: https://510kreport.com/methodology