# K140467: Flex-MT +

- Pathway: 510(k) (Traditional)
- Applicant: Emsi
- Decided: Oct 7, 2014 after 225 days
- Product code: IPF (Stimulator, Muscle, Powered)
- 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: 2 generations back to K931781 (1993). 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)
- K083030: Tens-Ems-14, Emsi (2009) Summary page 4.
- K021100: 300 PV Complete Electrotherapy System, Empi (2002) Summary page 4.

## 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/K140467
Methodology: https://510kreport.com/methodology