# K083030: Tens-Ems-14

- Pathway: 510(k) (Traditional)
- Applicant: Emsi
- Decided: Feb 5, 2009 after 118 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.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K140467: Flex-MT + (2014), 0 descendants of its own

## Indications for use
TENS- Transcutaneous Nerve Stimulation * Symptomatic relief of chronic intractable pain * Post traumatic and post surgical pain relief EMS- Electrical Muscle Stimulation * Relaxation of muscle spasm * Increasing local blood circulation * Muscle re-education. * Prevention or retardation'of disuse atrophy * Prevention of venous thrombosis of the calf muscles immediately after surgery * Maintaining or increase range of motion

Source page: https://510kreport.com/device/K083030
Methodology: https://510kreport.com/methodology